MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 95MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.195S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Failure of Implant (1924); 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) 2020 the patient underwent a revision surgery for stryker.Originally, the patient had an implantation surgery using a 5.0 mm titanium locking screw with t25, trochanteric fixation nail advanced fenestrated screw and 11mm titanium cannulated trochanteric fixation nail advanced in (b)(6) 2020.The screw was not placed through the nail.All hardware were successfully removed and was revised with a stryker gamma nail.Procedure outcomes and patient status are unknown.This report is for one tfna fenestrated screw 95 mm - sterile.This is report 2 of 2 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.H6: the complaint condition, that the fenestrated screw did not went through the nail, could be confirmed according to the received pictures and x-rays.H3, h4, h6: a device history record (dhr) review was conducted: manufacturing location: elmira ¿ packaged, labeled and released by: monument.Manufacturing date: 09-sep-2019, expiration date: 31-jul-2029, part number: 04.038.195s, tfna fenestrated screw 95mm -sterile, lot number: 16l3871 (sterile), lot quantity: 48.Part was manufactured by elmira; lot number: 14l6236.This lot met all 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 or Problem Description
It was further reported that the fenestrated lag screw was never placed through the nail.There was no allegation against the nail.Concomitant device reported: 5.0mm ti locking screw w/t25 stardrive 40mm for im nails (part number: 04.005.530, lot number: unknown, quantity: 1); 11mm/125 deg ti cann tfna 400mm/right - sterile (part # 04.037.130s, lot # h847439, quantity 1).

• Brand Name: TFNA FENESTRATED SCREW 95MM - 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: 9746866
• Report Number: 2939274-2020-01030
• Device Sequence Number: 1974516
• Product Code: HSB
• UDI-Device Identifier: 10886982098757
• UDI-Public: (01)10886982098757
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2020

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: 04.038.195S
• Device Catalogue Number: 04.038.195S
• Device Lot Number: 16L3871
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/02/2020
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 03/24/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11MM/125 DEG TI CANN TFNA 400MM/RIGHT - STERILE; 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 79