MAUDE Adverse Event Report: SYNTHES BETTLACH 5.0MM FLEXIBLE SHAFT; REAMER

Catalog Number 352.040

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Failure of Implant (1924); Sedation (2368); No Code Available (3191)

Event Date 04/21/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information not available for reporting.Device is an instrument and is not implanted/explanted.The complaint indicated that the device broke intraoperatively requiring additional surgical intervention in order to remove the device fragments subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records was conducted.The report indicates that the: manufacturing location: (b)(4), manufacturing date: 23 april 2014, part: 352.040 / lot: 8800572.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that a incident happened in (b)(6) hospital during surgery.Surgeons were having a surgery for ssfn synthes shaft fracture nailing right femur fixation surgery.Entry point had been opened and they started to ream the medullary canal.Surgeons had reamed till size 10.5mm.Upon taking out the 10.5mm synthes reamer, surgeon felt resistance and tightness.They checked through the c-arm and continue to pull and take out the reamer to change the head to 11.0mm.However, surgeon heard a cracking sound and continued to check using the c-arm.It was seen through the monitor that the reamer was broken.They then used the ball tip guide wire to pull out the reamer head.Upon removing the reamer shaft and reamer head size 10.5mm, they found that there are some metal chips from the reamer head remained in the patient's medullary canal.The surgeons then used a new reamer shaft with reamer heads smaller than 10.5mm to shove the remaining metal chips out into the fracture site.Surgeons then make an incision at the patient's mid shaft femur (fracture site) to remove the metal chips.All chips were able to be removed and there is none left in the patient.There were no patient harm, prolongation of the surgery: at least 30-45minutes were taken to remove the fragment pieces.Another incision was made for better access to remove fragment pieces, no reoperation.This complaint involves 2 parts.In addition, the quality engineers reviewed the product picture of the reamer shaft and determined that the distal prongs appear to be missing when the picture was comparted to the product drawing.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

(b)(6).(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A manufacturing investigation was performed for the subject device (5.0mm flexible shaft, part number 352.040, lot number 8800572).The subject device was returned with marks and striations consistent with frequent or forcible use.The shaft is slightly bent.The coupling prongs for the reamer heads on the tip were sheared off; only one completely twisted prong remains.The three broken-off, bent and twisted prongs were received for evaluation.The manner of wear and damage shows that the device was subjected to side load and torsional mechanical overloading.Because of the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.As previously reported, the device history record review shows that the device was manufactured in april 2014 and there were no issues during the manufacturing of the product that would have caused the complaint condition.No manufacturing related issues that would have contributed to this complaint were found.The root cause of this event is determined to be excessive force through the method of use and associated accumulated damage and wear.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.0MM FLEXIBLE SHAFT
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5643008
• MDR Text Key: 44812080
• Report Number: 9612488-2016-10230
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.040
• Device Lot Number: 8800572
• Other Device ID Number: (01)07611819243668(10)8800572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention