MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BOLT FOR FEMORAL NECK SYSTEM 90MM LENGTH-STERILE; APPLIANCE,FIXATION,NAIL

Model Number	04.168.290S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
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) 2019 the patient underwent a removal surgery due to a femoral neck system (fns) cut through to the femoral head.Originally, the patient was implanted with the fns system on an unknown date.The fns implants were removed and a hemiarthroplasty was performed.The surgery was completed with no adverse consequences to the patient.Concomitant devices: fns plate (part#: 04.168.000s, lot#: 5l62330, quantity#: 1); titanium (ti) locking screw (part#: 412.214s, lot#: 3l25990, quantity#: 1).This report is for one bolt for femoral neck system 90mm length-sterile.This is report 1 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.H3, h6: investigation summary: product was not returned.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 history lot: part: 04.168.290s-us.Lot: 3l26384.Manufacturing site: grenchen.Release to warehouse date: feb.06, 2019.Expiry date: dec.31, 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 90MM 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: 9591511
• Report Number: 2939274-2020-00197
• Device Sequence Number: 459062
• Product Code: KTT
• UDI-Device Identifier: 10886982274748
• UDI-Public: (01)10886982274748
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K172872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2019

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: 04.168.290S
• Device Catalogue Number: 04.168.290S
• Device Lot Number: 3L26384
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 02/06/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0MM TI LOCK SCR SLFTPNG WT25 STARDRIVE 40MM-STER; FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE
• Outcome Attributed to Adverse Event: Required Intervention