MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BOLT FOR FEMORAL NECK SYS 95 LENGTH-SILE; APPLIANCE,FIXATION,NAIL

Model Number	04.168.295S
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 (5) devices.This report is for (1) bolt for femoral neck system 95mm length-sterile.This report is 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The lot# 72p5643 corresponds to non-sterile article# 60123909 part # 60123909 lot # 72p5643 manufacturing site: grenchen release to warehouse date: 18 november 2020 a manufacturing record evaluation was performed for the non-sterile lot and no non-conformances were identified.Visual inspection: the bolt for femoral neck sys 95 length-sile (p/n: 04.168.295s, lot 72p5643) was returned and received at us customer quality (cq).Upon visual inspection, some minor scratches were observed on the device surface 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? 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: BOLT FOR FEMORAL NECK SYS 95 LENGTH-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: 12368394
• Report Number: 2939274-2021-04922
• Device Sequence Number: 4536526
• Product Code: KTT
• UDI-Device Identifier: 10886982274755
• UDI-Public: (01)10886982274755
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172872
• 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: 04.168.295S
• Device Catalogue Number: 04.168.295S
• Device Lot Number: 72P5643
• 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 48; 5.0 TI LCKNG SCR SLF-TPNG T25 SD REC 50; ANTIROTATION SCR FEM NECK 95 LNTH -S; FEMORAL NECK SYSTEM PL 2 HOLE - STERILE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR