MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BOLT FOR FEMORAL NECK SYSTEM 80MM LENGTH-STERILE; APPLIANCE,FIXATION,NAIL

Model Number	04.168.280S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Malunion of Bone (4529)
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.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, the patient underwent hip revision surgery due to malunion and femoral neck collapse.The surgeon removed one (1) femoral neck system plate, one (1) femoral neck bolt, one (1) antirotation femoral neck screw, and one (1) 5mm ti locking screw.The original procedure date is unknown.The hardware was removed with no issues.The patient was then implanted with a hip hemi arthroplasty.The procedure was successfully completed.This report is for one (1) bolt for femoral neck system 80mm length-sterile.This is report 2 of 4 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 batch number: 46p2061 corresponds to nonsterile part 60123906.Product code: 60123906, lot number: 46p2061, manufacturing site: grenchen, release to warehouse date: 26.March 2020.A manufacturing record evaluation was performed for the art# 60123906 lot number# 46p2061 , and no non-conformances were identified.A dhr review could not be performed for this pi.There is no record of the is part number or lot number ever having been manufactured by the monument facility.Please reassign this task to the correct group.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: BOLT FOR FEMORAL NECK SYSTEM 80MM LENGTH-STERILE
• 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: 11438925
• Report Number: 2939274-2021-01235
• Device Sequence Number: 14337429
• Product Code: KTT
• UDI-Device Identifier: 10886982274724
• UDI-Public: 10886982274724
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: 04.168.280S
• Device Catalogue Number: 04.168.280S
• Device Lot Number: 46P2061
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/02/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 38MM; ANTIROTATION SCREW FOR FEMORAL NECK SYS 80MM; FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE
• Outcome Attributed to Adverse Event: Required Intervention