Summary of MedSun Reports Describing Problem With Arthroscopic Shaver Blades and Burrs
MedSun: Newsletter #58, March 2011

Arthroscopic shaver blades and burrs are devices used for the resection of bone and tissue within the interior of a joint. These products are considered to be accessories to an arthroscope, which is defined as an, "electrically powered endoscope intended to make visible the interior of a joint." (21 C.F.R. pt 888.1100)

Many arthroscopic blades and burrs are initially marketed as single-use devices (SUD). The term "single-use device" refers to a device that is intended for one use, or on a single patient during a single procedure. A reprocessed SUD is an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. SUDs may be re-processed by another manufacturer if the device re-processor has received clearance from the Food and Drug Administration (FDA, 2009). The reports described in this summary include both SUDs and reprocessed SUDs.

Over the past 2 years, MedSun has received 44 adverse event reports associated with Arthroscopic Shaver devices manufactured by Ascent Healthcare Solutions, ConMed Linvatec, Smith & Nephew, and Stryker Endoscopy. The reports were submitted by 22 hospitals between February 2009 and February 2011.

The reported device problems were:
• 22 – Expulsion of metal debris during use
• 9 – Mechanical failure (e.g. blade breakage) during use
• 5 – Failure of the blade/burr to rotate
• 4 – Dullness of the blade/burr
• 3 – Compromised device sterility
• 1 – Out-of-the-box mechanical defect (e.g. blade/burr found to be bent)

None of the reported events involved a patient death or injury. Of the reports that listed patient age, 5 had a patient age listed as less than 21 years and 33 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 16 reports involved female patients and a total of 23 reports involved male patients.

These MedSun reports summarized above, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

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The following recall(s) are associated with arthroscopic shaver blades and systems since 2009. The Medsun Reported events may, or may not, be involved in the recall(s) listed.

Recall Number: Z-0825-2011
Date Posted: December 28, 2010
Product: Stryker brand End Cutter Shaver Blade F-Series, 4.0 mm; Model Number
-375-747-000
Code Information: Lot Number: 09203CE2
Recalling Firm/Manufacturer: Stryker Endoscopy
Action: Stryker issued Urgent Product Recall letters dated November 12, 2009 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were requested to return the product to Stryker. Stryker can be contacted concerning this recall at 408 754-2124.
Distribution: Nationwide Distribution: includes: Arizona, California, Colorado, Denver, Florida, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Michigan, New York, Ohio, and South Carolina.

Information online: http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfRES/res.cfm?id=88337

Recall Number: Z-1565-2009
Date Posted: July 14, 2009
Product: Smith & Nephew Endoscopic Disposable Blades: BOXED F/R,BL,4.5MM,SERIES 3000 /6 Product #: 7206011. DYONICS Series 3000 BONECUTTER
Code Information: Lot #: 20148714 and 20153849.
Recalling Firm/Manufacturer: Smith & Nephew, Inc. Endoscopy Division
Action: Smith & Nephew, Inc. issued a notification letter dated May 5, 2009 via Federal Express to User Facility and/or Sales Representatives on May 7, 2009 and an Email was sent to Sales Representatives. Accounts were requested to 1)complete the form and fax to Smith & Nephew, Inc. at 1-508-261-3636 and 2) return (using the firm's return authorization number) affected product to Smith & Nephew, Inc. Direct questions about this recall to Smith & Nephew, Inc. by calling 1-508-261-3655.
Distribution: Worldwide Distribution: -- US, Switzerland, Canada, United Arab Emerites, Belgium, Mexico, South Africa, Great Britain, Australia, Korea, Japan, Germany, Israel, India, Taiwan, Greece, Italy, Turkey and Chile

Information online: http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfRES/res.cfm?id=81979

Recall Number: Z-1564-2009
Date Posted: July 14, 2009
Product: Smith & Nephew Endoscopic Disposable Blades: DISPOSABLE BL,4.5MM FR ELITE Part #: 7210499. DYONICS Series 3000 BONECUTTER
Code Information: Lot #: 20153865.
Recalling Firm/Manufacturer: Smith & Nephew, Inc. Endoscopy Division
Action: Smith & Nephew, Inc. issued a notification letter dated May 5, 2009 via Federal Express to User Facility and/or Sales Representatives on May 7, 2009 and an Email was sent to Sales Representatives. Accounts were requested to 1)complete the form and fax to Smith & Nephew, Inc. at 1-508-261-3636 and 2) return (using the firm's return authorization number) affected product to Smith & Nephew, Inc. Direct questions about this recall to Smith & Nephew, Inc. by calling 1-508-261-3655.
Distribution: Worldwide Distribution: -- US, Switzerland, Canada, United Arab Emerites, Belgium, Mexico, South Africa, Great Britain, Australia, Korea, Japan, Germany, Israel, India, Taiwan, Greece, Italy, Turkey and Chile.

Information online: http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfRES/res.cfm?id=81978

Recall Number: Z-1560-2009
Date Posted: July 14, 2009
Product: Smith & Nephew Endoscopic Disposable Blades: FULL RADIUS BLADE, 5.5MM,SER
3000 Part #: 7206010. DYONICS Series 3000 BONECUTTER
Code Information: Lot #: 20154971 and 20148707.
Recalling Firm/Manufacturer: Smith & Nephew, Inc. Endoscopy Division
Action: Smith & Nephew, Inc. issued a notification letter dated May 5, 2009 via Federal Express to User Facility and/or Sales Representatives on May 7, 2009 and an Email was sent to Sales Representatives. Accounts were requested to 1)complete the form and fax to Smith & Nephew, Inc. at 1-508-261-3636 and 2) return (using the firm's return authorization number) affected product to Smith & Nephew, Inc. Direct questions about this recall to Smith & Nephew, Inc. by calling 1-508-261-3655
Distribution: Worldwide Distribution: -- US, Switzerland, Canada, United Arab Emerites, Belgium, Mexico, South Africa, Great Britain, Australia, Korea, Japan, Germany, Israel, India, Taiwan, Greece, Italy, Turkey and Chile

Information online: http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfRES/res.cfm?id=81974

Recall Number: Z-1561-2009
Date Posted: July 14, 2009
Product: Smith & Nephew Endoscopic Disposable Blades: STONECUTTER ACR,4.0,EP-1,DSP
Part #: 7205330. DYONICS Series 3000 BONECUTTER
Code Information: Lot #: 20153856.
Recalling Firm/Manufacturer: Smith & Nephew, Inc. Endoscopy Division
Action:
Distribution: Worldwide Distribution: -- US, Switzerland, Canada, United Arab Emerites, Belgium, Mexico, South Africa, Great Britain, Australia, Korea, Japan, Germany, Israel, India, Taiwan, Greece, Italy, Turkey and Chile.

Information online: http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfRES/res.cfm?id=81975

Recall Number: Z-1566-2009
Date Posted: July 14, 2009
Product: Smith & Nephew Endoscopic Disposable Blades: INCISOR BLADE,3.5MM DSPL,EP-1
Part #: 7205312. DYONICS Series 3000 BONECUTTER
Code Information: Lot #: 20153858.
Recalling Firm/Manufacturer: Smith & Nephew, Inc. Endoscopy Division
Action: Smith & Nephew, Inc. issued a notification letter dated May 5, 2009 via Federal Express to User Facility and/or Sales Representatives on May 7, 2009 and an Email was sent to Sales Representatives. Accounts were requested to 1)complete the form and fax to Smith & Nephew, Inc. at 1-508-261-3636 and 2) return (using the firm's return authorization number) affected product to Smith & Nephew, Inc. Direct questions about this recall to Smith & Nephew, Inc. by calling 1-508-261-3655.
Distribution: Worldwide Distribution: -- US, Switzerland, Canada, United Arab Emerites, Belgium, Mexico, South Africa, Great Britain, Australia, Korea, Japan, Germany, Israel, India, Taiwan, Greece, Italy, Turkey and Chile.

Information online: http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfRES/res.cfm?id=81980

Recall Number: Z-1562-2009
Date Posted: July 14, 2009
Product: Smith & Nephew Endoscopic Disposable Blades: NOTCHBLASTER ABR,EP-1,5.5 DSPL
Part #: 7205329. DYONICS Series 3000 BONECUTTER
Code Information: Lot #: 20153855
Recalling Firm/Manufacturer: Smith & Nephew, Inc. Endoscopy Division
Action: Smith & Nephew, Inc. issued a notification letter dated May 5, 2009 via Federal Express to User Facility and/or Sales Representatives on May 7, 2009 and an Email was sent to Sales Representatives. Accounts were requested to 1)complete the form and fax to Smith & Nephew, Inc. at 1-508-261-3636 and 2) return (using the firm's return authorization number) affected product to Smith & Nephew, Inc. Direct questions about this recall to Smith & Nephew, Inc. by calling 1-508-261-3655.
Distribution: Worldwide Distribution: -- US, Switzerland, Canada, United Arab Emerites, Belgium, Mexico, South Africa, Great Britain, Australia, Korea, Japan, Germany, Israel, India, Taiwan, Greece, Italy, Turkey and Chile.

Information online: http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfRES/res.cfm?id=81976

Recall Number: Z-1567-2009
Date Posted: July 14, 2009
Product: Smith & Nephew Endoscopic Disposable Blades:TURBOWHISKER BLD,EP-1,4.5MM(6)
Part #: 7205316. DYONICS Series 3000 BONECUTTER
Code Information: Lot # : 20153874.
Recalling Firm/Manufacturer: Smith & Nephew, Inc. Endoscopy Division
Action: Smith & Nephew, Inc. issued a notification letter dated May 5, 2009 via Federal Express to User Facility and/or Sales Representatives on May 7, 2009 and an Email was sent to Sales Representatives. Accounts were requested to 1)complete the form and fax to Smith & Nephew, Inc. at 1-508-261-3636 and 2) return (using the firm's return authorization number) affected product to Smith & Nephew, Inc. Direct questions about this recall to Smith & Nephew, Inc. by calling 1-508-261-3655
Distribution: Worldwide Distribution: -- US, Switzerland, Canada, United Arab Emerites, Belgium, Mexico, South Africa, Great Britain, Australia, Korea, Japan, Germany, Israel, India, Taiwan, Greece, Italy, Turkey and Chile.

Information online: http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfRES/res.cfm?id=81982


The following table lists the MedSun reports that are described in the device problem summary above.
[Note: The reports have been edited for clarity]

Reports of Problems with Arthroscopic Shaver Blades and Burrs
DeviceCatalog Number, Model Number, Lot Number Event Description
Smith & Nephew, Inc.,, Dyonics Synovator 7205334, N/A, 50530083 Male patient was undergoing right shoulder arthroscopy, arthroscopic biceps tenodesis, anterior bankart repair, posterior bankart repair and rotator cuff repair. Surgeon placed shaver inside shoulder and turned the device on. Immediately after the shaver was turned on it began to spit out metal shavings. The arthroscopic shaver was immediately removed from the field and the patient's shoulder was irrigated copiously. Another device was obtained and the procedure was completed with no further issues. There was no injury to the patient. The equipment was sequestered for risk management.
Smith & Nephew, Inc., Dyonics Full Radius Elite 7210909, C9405A, 50551426 The arthroscopic surgery blade is used to shave the ligament. This device is used in most arthroscopic procedures. Prior to shaving the physician noticed the distal tip was bent. The physician secured a second blade and completed the procedure without incident. There was no patient harm.
Smith & Nephew, Inc., Dyonics Synovator 7205334 , N/A, 50261 Patient was taken to surgery for right knee arthroscopy with meniscus repair. Upon using the smith and nephew Dyonics 4.5mm Synovator blade, metal like fragments were given off by the instrument. The surgeon immediately stopped using the instrument and removed it from the field. The device was in oscillating mode, was shaving the patient's meniscus and was not being torqued in any manner. The surgeon flushed out the fragments with copious amounts of saline to flush out the particulate. Another Synovator blade was used to finish the procedure. There was no injury to the patient, who was sent to the PACU for recovery after the procedure was finished.
Smith & Nephew, Inc., Dyonics Stonecutter 7205330 , N/A, 50546377 During room set up, it was noticed that the blade was sticking. The device was removed immediately and never made it to the pt.
Smith & Nephew, Inc., Dyonics Synovator 7205334, N/A, 50530083 Patient was taken to surgery for knee arthroscopy and meniscectomy. While using the smith and nephew curved Synovator blade the surgeon encountered a problem in that the shaver was "binding up" and not rotating freely (this instrument should spin freely allowing the surgeon to shave bone as needed in orthopedic surgical cases). Once this problem was encountered the surgeon stopped using the Synovator and utilized another device to complete the case. The procedure was finished and the patient was sent to the PACU for recovery. The device was retained for risk management. There was no injury to the patient.
Smith & Nephew, Inc., Dyonics Synovator 7205334, 375941000, 50530083 Patient taken to surgery for arthroscopy of the left knee with partial lateral meniscectomy. Upon using the smith and nephew Dyonics arthroscopic surgery blade, it appeared to start "flaking" at the sharp shaving point, leaving metal shavings in the patient's joint. Surgeon immediately discontinued use of the shaver and irrigated the pt's joint with copious amounts of saline to flush out the shavings until none were visible. Another shaver was used to complete the procedure. No further issues were noted. Patient tolerated the procedure well and was sent to the PACU for recovery.
Stryker Endoscopy, Formula Aggressive Plus 375-544-000, N/A, 10273CE2 During arthroscopy metal fragments were identified floating in the knee space. The physician stopped the procedure, irrigated and suctioned-out all the fragments from the knee space. A new shaver was obtained and the procedure was continued.
Smith & Nephew, Inc., Dyonics Incisor Plus Elite 7210976, , N/A, 50551293 Adolescent was taken to surgery to repair a right knee lateral bucket-handle meniscal tear. During arthroscopy, the smith and nephew Dyonics arthroscopic surgery incisor plus elite blade gave off what was believed to be small metal fragments in the pt's joint. The surgeon stopped using the blade and thoroughly irrigated the joint to flush out all the fragments. The MD was able to use a different blade to finish the procedure. There was no injury to the pt. The blade was sequestered and bagged for risk management pick-up. The patient tolerated the procedure well and was sent to the PACU for recovery
Ascent Healthcare Solutions, Formula Aggressive Plus 375-544-000, N/A, 1316606 The tip of the shaver blade broke off while the surgeon was doing an arthroscopy on the patient's right knee. The surgeon had to retrieve the broken piece from the patient's right knee.
Smith & Nephew, Inc., Dyonics Synovator N/A, N/A, Surgical technician reports, while testing equipment prior to a surgical procedure, it was noted the 4.5 mm curved arthroscopic shaver would not "spin." two more shavers of the same type and lot number were opened and also would not work properly. They would not spin effectively when attached to the surgical drill. A straight shaver (same manufacturer/different model number) was tested and worked appropriately. This replacement shaver was used for the remainder of the procedure. Once the procedure was complete the surgical technician bagged the shavers which were tested and did not work. He also removed 10 more shavers from the same lot number off of our shelves. Product has been retained in risk management and will be returned, upon request, to the manufacturer for testing purposes. There was no injury to the patient since products never reached the surgical field.
Smith & Nephew, Inc., Dyonics 7205315, N/A, 50541073 Elderly patient was taken to the or for left knee arthroscopy. During the procedure it was noted the smith & nephew Dyonics 4.5mm Turbotrimmer blade (shaver) appeared to be producing small metallic shavings. Or staff changed out the shaver blade and proceeded with the case with no further issues noted. Staff report it appeared shavings were washed out of knee capsule and the surgeon did not direct staff to do anything else in regards to this. Patient was sent to the PACU for recovery and was discharged home. The device was retained and sequestered for risk management pick up. Of note, we have had reports of this previously with other devices from other manufacturers and was told this may be "lubricant" flaking off. We have also seen this issue with reprocessed shavers from this same manufacturer. No apparent injury or impact to patient.
Ascent Healthcare Solutions, Formula 375-941-012, ES-9263A, 1112775 AS THE SURGEON WAS PERFORMING SHOULDER ARTHROSCOPY, THE 4MM SHAVER BLADE HE WAS USING EXPELLED PIECES OF METAL.
Conmed Corp., Sterling Full Radius Resector C9248, 9263A, 193035 During a procedure, the MD tried to use a full radius resector and the device failed to spin. The device was removed from the site and the MD tried to clean out the sheath. It was noted that the inner part of the resector had broken in half, no part was missing. The part was replaced and surgery continued. No harm to the patient.
Ascent Healthcare Solutions, Dyonics Stonecutter N/A, N/A, 1209432 Patient was in the or for left shoulder arthroscopy. During the procedure the orthopedic surgeon felt the reprocessed Dyonics stonecutter shaver was dull. Surgeon was able to complete procedure with the device but felt the device did not perform to the standards he was used to seeing. Note this was a different orthopedic surgeon than those described in the 2 previous dull shaver blade reports. There was no injury to the patient.
Ascent Healthcare Solutions, Dyonics Notchblaster 7205329, N/A, 1045689 Patients were scheduled for right ACL reconstruction surgery. During both procedures, while the orthopedic surgeon was using Dyonics reprocessed Notchblasters, he noted the burrs to be dull while in use. The devices did work, but the surgeon felt the devices were not as effective as compared to new or unused arthroscopic burrs. Of note, these were two separate procedures for two separate patients. Both devices are from the same lot number and both have been retained for evaluation purposes. There was no injury to the patients; however extra surgical time was necessary to ensure each Notchblaster completed the task they were used for.
Linvatec Corp., Sterling Tiger C9242, 375-940-000, 187829 Shaver was in use when a piece of the device went "off field" and into the patient's knee.
Ascent Healthcare Solutions, Dyonics Incisor Plus Elite N/A, N/A, 1221408 ADULT MALE TAKEN TO OR FOR ROTATOR CUFF REPAIR PROCEDURE. DURING THE SURGERY THE SURGEON WAS USING A REPROCESSED DYONICS (A SMITH & NEPHEW COMPANY) TURBO TRIMMER AND INCISOR PLUS ELITE SHAVER WHICH BOTH GAVE OFF WHAT APPEARED TO BE METAL SHAVINGS OR PARTICULATE WHEN USED. THE SURGEON NOTED SHAVINGS AND/OR PARTICULATE IN THE PATIENT'S JOINT. SURGEON HAD TO USE A HIGH-FLOW LAVAGE TO IRRIGATE THE METAL FRAGMENTS OUT OF THE SURGICAL SITE. SURGEON'S NOTE INDICATED THIS LAVAGE WAS SUCCESSFUL AND IT IS BELIEVED NO FRAGMENTS WERE RETAINED. BOTH SHAVERS WERE TAKEN OUT OF SERVICE AND SEQUESTERED FOR RISK MANAGEMENT. THERE WAS NO HARM OR INJURY TO THE PATIENT. SURGEON DID UTILIZE A THIRD SHAVER WHICH WORKED APPROPRIATELY WITHOUT GIVING OFF ANY SHAVINGS. PROCEDURE WAS FINISHED WITH NO FURTHER ISSUE.
Ascent Healthcare Solutions, Formula Round Bur 12 Flute 375-940-012, N/A, 1072147 Reprocessed shaver blade ascent formula round burr 12 flute used for case, metal shavings noted on video. Shaver blade changed, wound irrigated, no obvious metal shavings, reprocessed blades removed from or core supply.
Ascent Healthcare Solutions, Formula Aggressive Plus Cutter N/A, Bonecutter, 1145308 Cutter broke off at tip. Broken tip was retrieved.
Smith & Nephew, Inc., N/A N/A, N/A, 50515812 Metal findings emitted from arthroscopic shaver during knee scope.
Ascent Healthcare Solutions, Formula Aggressive Plus Cutter 375-564-000, Tomcat, 914742 The surgeon was using the device when he observed one of the blades had bent upward. The device was removed immediately and appeared to be intact.
Stryker Endoscopy, Formula Round Bur 6-Flute 375-940-000, 375-534-000, 10154CE2 A 4.0mm aggressive plus and 4.0mm burr (Stryker arthroscopic shavers) sterile packaged from the company were placed on the field in a sterile fashion. The scrub noted a white thick greasy substance on both the burr and incisor - the tips were removed from the field - packages were saved and devices bagged.
Ascent Healthcare Solutions, Formula Aggressive Plus Cutter 3.5mm N/A, N/A, 969549 Stryker aggressive plus cutter 3.5 mm that was reprocessed by ascent. Upon insertion, the MD noticed silver particles falling on the meniscus prior to any shavings being performed. Item taken off field and given to or manager. Wound flushed several times.
Stryker Endoscopy, Formula Tomcat 375-545-000, N/A, N/A During a shoulder arthroscopy, the surgeon reported seeing what appeared to be metal shavings from a stryker brand disposable arthroscopy blade. No patient injury was noted, since the area was thoroughly flushed and suctioned to remove all traces of the metal shavings. The stryker representative was notified and all blades from our inventory were replaced with blades from a different lot.
Stryker Instruments, Instruments Div, Formula Aggressive Plus N/A, N/A, 753682 Cutter blade broke off out of shaver stem while in use. Metallic element was recovered by surgeon; however, x-ray was requested by surgeon to be done in PACU to rule out (r/o) any possibility of left behind fragments. No harm to the patient.
N/A, N/A N/A, N/A, N/A Cutter blade broke off out of shaver stem while in use. Metallic element was recovered by surgeon.
Smith & Nephew, Inc., Dyonics Bonecutter 7206010, 375-544-000, 996654 After just a few seconds of use under no particular lateral strain the reprocessed shaver blade started to spew out metal filings into the irrigated space during right knee arthroscopy. These appeared as glitter on the video screen. The area was rinsed out and no filings were left in the patient. A new, un-reprocessed blade was used after that with no difficulties encountered.
Ascent Healthcare Solutions, Formula Resector Cutter 375-562-000, N/A, 165724 The patient was having right shoulder arthroscopic debridement, subacromial decompression, distal clavicle resection, open rotator cuff repair, and open biceps tenodesis, right shoulder. The surgeon made a 4 cm incision across the anterolateral aspect of the shoulder. Dissection was carried through the subcutaneous tissue and the anterolateral border from the acromion was opened as was the deltoid split between the anterolateral heads. The rotator cuff tear was identified. The surgeon took a bur and debrided the bone to allow good bleeding. The surgeon then used pull stitches to mobilize the rotator cuff. Once the bur was used, it was noted that it left tiny pieces of metal in the patient's shoulder.
Ascent Healthcare Solutions, Formula Agressive 6 Flute 375-940-000, N/A, 140679 The male patient was having left shoulder arthoscopic rotator cuff repair, subacromial decompression, distal clavicle resection and debridement of a type 1 superior labral tear. The physician noted the patient did have a type 1 slap tear. His subscapularis tendon was intact. The type 1 slap lesion was debrided using a motorized shaver. After this was accomplished, the patient was noted to have a small, full-thickness rotator cuff tear that could be observed from the undersurface. This area was marked. The subacromial space was entered. Subacromial decompression was performed using a motorized bur. Once the bur was used, it was noted that it left very tiny flakes of metal inside the patient's shoulder.
Smith & Nephew Inc., Endoscopy Div., Dyonics 72200080, 7205330, N/A Surgeon performing arthroscopy of patient's right ankle using 2 different Dyonics arthroscopic surgery blades. One noted to disintegrate upon use (shavings visible on video monitor) and another appeared to be winding tightly when end of shaver outside patient snapped off. Instruments were replaced and surgery completed without apparent injury to patient.
Ascent Healthcare Solutions, Gator 9263A, 375-941-012, 756924 - ASCENT LOT# A 4.2mm arthroscopic shaver, remanufactured by ascent, began to leave what appeared to be metal shavings in the patients knee during an arthoscopy of the knee. This was noticed immediately by the surgeon and the shaver's use was discontinued. A new product was obtained that had not been remanufactured. The debris was suctioned out and irrigated. The procedure continued without incident.
Linvatec Corp., Gator 9263A, N/A, 756924 - ASCENT LOT # Procedure: right shoulder arthroscopy with rotator cuff repair. Used an ascent reprocessed gator blade 4.2mm x 13 cm ref. *596a lot # 756924 2009-07. The doctor noted metal shavings being left behind in shoulder while using gator blade on the handpiece durnig the procedure.
Stryker Endoscopy, Formula 375747000, 7210976; 7205315, 09203CE2 Metal piece broke off end cutter. Metal piece was retrieved. Fluoroscopy confirmed there was no retained foreign body. No harm to patient.
Ascent Healthcare Solutions, Conmed Linvatek Blade H9101,C9248 ,67631 During a shoulder arthroscopy with glenohumeral debridement acromioplasty distal clavicle resection, it was noted that there appeared to be minute metal shavings in the space/wound. Irrigated copiously until clear.
Ascent Healthcare Solutions, Formula 375-542-000, 7205315 ,676560 During the case the blade was "dull, not sharp."
Ascent Healthcare Solutions, Formula 375-941-000, 7205334 ,676230 During use, a lot of metal debris was seen floating; presumed to be from the bur. The debris was suctioned out.
Ascent Healthcare Solutions, Formula 375-542-000, 375-544-000, 676560 During the case it was noted that this burr was dull ("not sharp"). No other problems associated with the burr.
Stryker Endoscopy,.Formula 180 N/A, 7210976, 08226CE2 During the case observed on screen multiple metal flecks floating while presumably using the Stryker barrel bur. Surgeon suctioned them out.
Ascent Healthcare Solutions, Blade 7205305, 7210909, 210573 Device clogged and would not function.
Stryker Endoscopy, Formula Core And Formula 180 N/A, 7205334, N/A Stryker issuing a cleaning reminder to ensure tissue does not remain on shaver (prior to sterilization).
Stryker Endoscopy, Agressive Plus 375544000, 7205334, 675348 Surgeon reported that blade was "grinding on itself", was ineffective.
Smith & Nephew, Inc., N/A 720611, 375-544-000, N/A Recall of resection blades that may have breached sterile barrier. Warehouse discarded blades in stock.
Linvatec Corp., Ultracut C9405A, 7205334, BBF22361 During shoulder arthroscopy a 4.2mm Ultracut disposable blade was used and physician found metal shavings inside the patient's shoulder, coming off of or out of the shaver blade. A second blade was opened and utilized, with no problems to finish procedure. Physician washed the shavings out of the patient's shoulder.
Stryker Endoscopy, Small Joint Aggressive Cutter 375628000, 7205330, 08224CE2 During wrist arthroscopy Stryker shaver blade broke off in patient's wrist times two, two different blades.


Additional Information:

US Food and Drug Administration, Medical Devices, List of Single-Use Devices Known To Be Reprocessed or Considered for Reprocessing, Retrieved February 18, 2011,from US Department of Health and Human Services Web site:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/ucm121090.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun