MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.961S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.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 revision surgery due to a broken trochanteric fixation nail-advanced (tfna) nail implant.The implant broke at the patient fracture site.Patient and procedure outcome are unknown.Concomitant device reported: tfna helical blade (part/lot unknown, quantity 1); locking screw (part/lot unknown, quantity unknown).This report is for a tfna nail.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: 16-may-2017.Expiration date: 30-apr-2027.Part number: 04.037.961s, 9mm/130 deg ti cann tfna 400mm/left- sterile.Lot number: h366186 (sterile) 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 parts reviewed: part number: 04.037.912.4, wave spring, shim ended, bp55.Lot number: h249484.Part number: 04.037.942.2, lock prong, 130 degree tfna, bp55.Lot number: l376203.Part number: 04.037.912.3, tfna lock drive, bp58.Lot number: h349799.Part number: 21127, timoagri16.00, bp80.Lot number: h625377.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.
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 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: 9MM/130 DEG TI CANN TFNA 400MM/LEFT - 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: 8601552
• Report Number: 2939274-2019-57972
• Device Sequence Number: 13971770
• Product Code: HSB
• UDI-Device Identifier: 10886982098214
• UDI-Public: (01)10886982098214
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2019

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: 04.037.961S
• Device Catalogue Number: 04.037.961S
• Device Lot Number: H366186
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2019
• Supplement Date Received by Manufacturer: 06/11/2019; 06/11/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 06/12/2019; 06/12/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: LOCKING; UNK TFNA HELICAL BLADE; UNK - SCREWS: LOCKING; UNK TFNA HELICAL BLADE
• Outcome Attributed to Adverse Event: Required Intervention