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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 420MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 420MM/RIGHT - STERILE ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 04.037.162S
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Malunion of Bone (4529)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Investigation summary: the device was not returned. A photo-investigation was performed on the images. The x-ray images depicted an implanted nail that broke at the head element hole. No other product issues were noted. No device identifiers were visible. As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed. Conclusion: the complaint condition was confirmed during photo investigation. During the investigation, no product design issues or discrepancies were observed. No manufacturing issues were noted during investigation. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Therefore, it has been determined that no corrective and/or preventive action is proposed. Device history lot: manufacturing location: (b)(4), manufacturing date: sep 26, 2018, expiration date: aug 31, 2028, part number: 04. 037. 162s, 11mm/130 deg ti cann tfna 420mm / right ¿ sterile, lot number: h740119 (sterile). Work order traveler met all inspection acceptance criteria. Inspection sheet, in process / inspect dimensional / final, ns071295 rev d met all inspection acceptance criteria. Inspection sheet, tfna assembly inspection, ns067861 rev b met all inspection acceptance criteria. Packaging label log (pll) lppf rev d, lmd rev a was reviewed and determined to be conforming. Scn (b)(4) supplied by (b)(4) was reviewed and determined to be conforming. This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. Component part(s) reviewed: part number: 04. 037. 942. 2, lock prong, 130 degree, tfna bp55, lot number: l938659. Purchased finished goods traveler met all inspection acceptance criteria. Part number: 04. 037. 912. 4, wave spring, shim ended bp55. Lot number: h571523. Work order traveler met all inspection acceptance criteria. Inspection sheet, incoming final inspection ns062851 rev b met all inspection acceptance criteria. Material certification and certificate of conformance and quality history card supplied by (b)(4) dated 26-jun-2018 were reviewed and determined to be conforming. Part number: 04. 037. 912. 3, tfna lock drive bp58. Lot number: h717663. One piece was scrapped in cell at op #10, machine complete, after a machine malfunction. Work order traveler met all inspection acceptance criteria apart from the one piece noted. Inspection sheet ns062925 rev e met all inspection acceptance criteria. Part number: 21127, timoagri16. 00 bp80, lot number: h699161. Certified test report supplied by (b)(4) dated 14-jun-2018 and certificate of analysis supplied to (b)(4) dated 12-may-2016 were reviewed and determined to be conforming. Lot summary report dated 25-jul-2018 met all inspection acceptance criteria. Raw material receiving / putaway checklist met all inspection acceptance criteria. Device history review: this lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. 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.
 
Event Description
It was reported that on (b)(6) 2020, the patient underwent revision and hardware removal due to nonunion, malunion, and a broken proximal femoral nailing system (tfna) nail. There was a clinical finding which was delayed healing. Fragments from the broken device were removed with difficulty. The patient was revised using a 95 degree blade plate. The procedure was successfully completed with approximately thirty (30) minutes of surgical delay. The patient status is unknown. Concomitant device reported: tfna lag screw (part#: 04. 038. 215, lot#: h417934, quantity: 1); titanium locking screw (part#: unknown, lot#: unknown, quantity: 2); unknown extractor; (part#: unknown, lot#: unknown, quantity: 2); unknown drill (part#: unknown, lot#: unknown, quantity: 2). This report is for one (1) 11mm/130 deg ti cann tfna 420mm/right - sterile. This is report 1 of 1 for (b)(4).
 
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Brand Name11MM/130 DEG TI CANN TFNA 420MM/RIGHT - STERILE
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key10905054
MDR Text Key218719309
Report Number2939274-2020-05302
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number04.037.162S
Device Catalogue Number04.037.162S
Device Lot NumberH740119
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/26/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/25/2020 Patient Sequence Number: 1
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