MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC FEMORAL NECK SYSTEM PLATE 2 HOLE - STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	04.268.000S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the complainant part will be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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 a patient underwent the femoral neck system (fns) removal on (b)(6) 2021 due to fns nail breakage.The implant broke at the locking screw hole.The physician stated the canal neck fracture was a nonunion and the implant broke due to non-union.No further information provided.Concomitant device reported: locking screw (part # unknown, lot # unknown, quantity 1).This report is for one (1) femoral neck system plate 2 hole - sterile.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.H10 additional narrative: part: 04.268.000s (component 60123892), lot: 1l60067, manufacturing site: grenchen, release to warehouse date: december 19, 2018, expiry date: december 1, 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the femoral neck system plate 2 hole - sterile (p/n: 04.268.000s, lot number: 1l60067) was received at us customer quality cq.Visual inspection of the complaint device showed the plate neck had broken.No material deficiencies were observed.Device failure/defect identified? yes.Dimensional inspection: measured dimensions: neck thickness = conforming.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the plate neck had broken.No definitive root cause could be determined based on the provided information.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.
Event or Problem Description
Updated event description: it was reported that a patient underwent the femoral neck system (fns) removal on (b)(6), 2021 due to fns plate breakage.The implant broke at the locking screw hole.The physician stated the canal neck fracture was a nonunion and the implant broke due to non-union.The procedure was successfully completed.The surgery was a planned removal for a hip replacement.This report is for one (1) femoral neck system plate 2 hole - sterile 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.H10 additional narrative: report was initially submitted on march 1, 2021.Advised by fda on march 23, 2021 to resubmit medwatch.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.E1: corrected reporter's name.

• Brand Name: FEMORAL NECK SYSTEM PLATE 2 HOLE - STERILE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11287185
• Report Number: 2939274-2021-00715
• Device Sequence Number: 3846035
• Product Code: KTT
• UDI-Device Identifier: 10886982274458
• UDI-Public: (01)10886982274458
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.268.000S
• Device Catalogue Number: 04.268.000S
• Device Lot Number: 1L60067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 03/12/2021; 03/12/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 03/23/2021; 03/23/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0MM TI LOCKING SCR SLF-TPNG 40MM; 5.0MM TI LOCKING SCR SLF-TPNG 44MM; UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION; UNK - NAIL HEAD ELEMENTS: FNS BOLT; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention