MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 440MM/RIGHT-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.264S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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.(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.
Event or Problem Description
It was reported that on (b)(6) 2019 the patient underwent a hardware removal and implantation of a femoral recon nail due to a broken trochanteric fixation nail advanced (tfna) long nail.Originally, the patient was implanted with tfn-advanced system long nail for a comminuted right subtrochanteric femur fracture on (b)(6) 2019.The patient was in physical therapy and doing a one-legged stance exercise and felt pain.Upon a routine follow up with the surgeon, it was found that the tfn-advanced system long nail broke.Revision surgery was done for the nonunion, the tfn-advanced system long nail was removed, and the patient was implanted with a femoral recon nail.It is unknown if there was a surgical delay.The procedure outcome.There was a patient consequence.Concomitant devices: unknown helical blade tfna (part# unknown, lot# unknown, quantity# 1), unknown screw (part# unknown, lot# unknown, quantity# unknown).This report is for one (1) 12 mm/130 deg ti cann tfna 440 mm/right-sterile.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device history lot.Manufacturing location: monument.Manufacturing date: oct 31, 2018.Expiration date: sep 30, 2028.Part number: 04.037.264s, 12mm/130 deg ti cann tfna 440mm/right- sterile.Lot number: h765035 (sterile).Lot quantity: 6.Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process/inspect dimensional/final ns071310 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 c, lmd rev a was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 15636 supplied by ethicon (abq) 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: 04.037.912.4, wave spring, shim ended, bp55.Lot number: h613112.Lot quantity: 999.One piece was scrapped in cell at op #20, incoming inspection, after being dropped.Work order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, incoming final inspection, ns062851 rev b met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card received from smalley dated (b)(6) 2018 were reviewed and determined to be conforming.Part number: 04.037.942.2, lock prong, 130 degree, tfna, bp55.Lot number: 1l34290.Lot quantity: 96.Purchased finished goods traveler met all inspection acceptance criteria.Part number: 04.037.912.3, tfna lock drive, bp58.Lot number: h750322.Lot quantity: 80.Work order traveler met all inspection acceptance criteria.Inspection sheet, ns062925 rev e met all inspection acceptance criteria.Part number: 21127, timoagri16.00, bp80.Lot number: h737247.Lot quantity: 2,372 lbs.Certificate of analysis received from metalwerks pmd dated (b)(6) 2018 was reviewed and determined to be conforming.Lot summary report dated (b)(6) 2018 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.Device history review.(b)(6) 2019: dhr reviewed.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.

• Brand Name: 12MM/130 DEG TI CANN TFNA 440MM/RIGHT-STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9311560
• Report Number: 2939274-2019-62120
• Device Sequence Number: 460125
• Product Code: HSB
• UDI-Device Identifier: 10886982097446
• UDI-Public: (01)10886982097446
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.037.264S
• Device Catalogue Number: 04.037.264S
• Device Lot Number: H765035
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 12/13/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 99