MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TROCHANTERIC FIXATION NAIL SCREW INSERTER/EXTRACTOR; ROD,FIXATION,INTRAMEDULLARY

Model Number	357.428
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product codes: hwc.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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.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
Device report from synthes reports an event in (b)(4) as follows: it was reported that on (b)(6) 2020, during an unknown surgery that the tfn screw was difficult to insert.Upon inspection, post-surgery, the prongs on the end of the tfn screw inserter/extractor were noted to be damaged/warped.The surgery was completed successfully.No fragments were generated.There was no reported consequence to the patient.Concomitant device reported: tfn screw (part number unknown, lot unknown, quantity unknown).This report involves 1 trochanteric fixation nail screw inserter/extractor.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.H3, h4, h6: part: 357.428, lot: 7878764, manufacturing site: hägendorf, release to warehouse date: 22 may 2012.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the insert/extractor f/tfn fem neck screw (p/n: 357.428, lot number: 7878764) was received at us customer quality (cq).Upon visual inspection, the distal tip prongs were worn out and the sides of the hexagonal were stripped.No other damage or issue were observed.Functional test: functional assessment was not perform due to not returning the mating device.Can the complaint be replicated with the returned device? unable to perform due to not returning the mating device.Document/specification review: the following drawings were reviewed current and manufactured - inserter/extractor tfn screw.Current and manufactured - - handle ftn screw current and manufactured - cannulated shaft tfn screw no design issues or discrepancies were identified.Dimensional inspection: measured dimensions: prongs width- conform shaft small- conform shaft big od- conform.Complaint confirmed? yes.Conclusion: the overall complaint was confirmed for the insert/extractor f/tfn fem neck screw (p/n: 357.428, lot number: 7878764) as the distal tip prongs were worn out and the sides of the hexagonal were stripped.This physical damage could contribute to the device being difficult to insert or connect into the other device leading to the difficulties experienced by the surgeon.No definitive root cause could be determined based on the provided information but this type of failure mode observed on the device is noticed when the device likely reach its end of life.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: TROCHANTERIC FIXATION NAIL SCREW INSERTER/EXTRACTOR
• 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: 10157349
• Report Number: 2939274-2020-02806
• Device Sequence Number: 2823677
• Product Code: HSB
• UDI-Device Identifier: 10886982196460
• UDI-Public: (01)10886982196460
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K092646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 357.428
• Device Catalogue Number: 357.428
• Device Lot Number: 7878764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA