MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0 TI LCKNG SCR SLF-TPNG T25 SD 48-SILE; APPLIANCE,FIXATION,NAIL

Model Number	412.218S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Event year is reported as 2021; however exact date of event is unknown.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
Event or Problem Description
It was reported that on (b)(6) 2021, patient underwent a hardware removal and revision surgery due to periprosthetic fracture.Patient was treated with a femoral neck system on (b)(6) 2021 complained of continued pain postoperatively.A ct scan revealed a fracture distal to the plate of the fns.The patient was brought to the operating room on (b)(6) 2021; the fns hardware was removed and long trochanteric fixation nail, helical blade, and locking screw were inserted.It was unknown if the surgery completed successfully.The patient outcome was unknown.This complaint involves five(5) devices.This report is for (1) 5.0 ti lckng scr slf-tpng t25 sd 48-sile.This report is 1 of 5 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 # 412.218s, lot # 60p2750, manufacturing site: mezzovico, release to warehouse date: 10 jul 2020, expiry:30 jun 2030.A manufacturing record evaluation was performed for the sterile lot number, and no non-conformances were identified.Visual inspection: the 5.0 ti lckng scr slf-tpng t25 sd 48-sile (p/n: 412.218s, lot #: 60p2750) was returned and received at us customer quality (cq).Upon visual inspection, some minor scratches were observed on the threaded portion of the screw likely due to the implantation and explantation, which was not related to the complaint condition.No other issues were observed with the returned device.Were any product issues/defects identified? yes.Appropriate investigation flow: damage.Dimensional inspection: the dimensional inspection was not performed on the retuned device since no such damage was warranted to do so.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed (current and manufactured) no design issues or discrepancies were identified.Complaint confirmed? no.Investigation conclusion the complaint was not confirmed.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative 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: 5.0 TI LCKNG SCR SLF-TPNG T25 SD 48-SILE
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12368388
• Report Number: 2939274-2021-04920
• Device Sequence Number: 11863840
• Product Code: KTT
• UDI-Device Identifier: 10886982275455
• UDI-Public: (01)10886982275455
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 412.218S
• Device Catalogue Number: 412.218S
• Device Lot Number: 60P2750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 09/27/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0 TI LCKNG SCR SLF-TPNG T25 SD REC 50; ANTIROTATION SCR FEM NECK 95 LNTH -S; BOLT FOR FEMORAL NECK SYS 95 LENGTH-SILE; FEMORAL NECK SYSTEM PL 2 HOLE - STERILE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR