MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9 MM / TI CANN FRN / GT 420MM / LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.033.973S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: reporter is synthes sales consultant.The device has been 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) 2020, the patient underwent a hardware removal due to the broken greater trochanter femoral recon nail (frn).The patient was implanted with depuy synthes femoral recon nail and zimmer biomet ncb plate.The revision surgery was completed successfully.This report captures the reported event of postop nail breakage while related complaint (b)(4) captures the intra-op event of broken screwdriver and driving cap.Concomitant devices reported: ti recon screws (part# unknown, lot# unknown, quantity unknown); locking screw (part# unknown, lot# unknown, quantity unknown); end cap (part# unknown, lot# unknown, quantity 1).This report is for one (1) 9mm/ti cann frn/gt 420mm/left-sterile.This is report 1 of 1 for complaint (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: a product investigation was conducted.Visual inspection: 9 mm / ti cann frn / gt 420mm / left ¿ sterile was received at us cq.Upon visual inspection at cq, it is observed that the nail got broken near distal tip.The broken part was also received at cq.The broken surface is homogenous without any voids or dark spots.There were few scratches and some discolored spots observed on the surface of the device which would not contribute to the complaint condition.Thus, the complaint is being confirmed.Dimensional inspection: dimensional inspection of the received device was performed at cq.The diameter of the nail near the broken location was measured which is within specification as per the relevant drawing.Document/ specification review: the relevant drawing(s) was reviewed; frn gt(tm) left d9-d14 femoral recon nail no design issues or discrepancies were found during this investigation.Investigation conclusion: visual inspection, dimensional inspection, and document specification review of the received device was performed at cq.The complaint is being confirmed as it is observed that the nail got broken near distal tip.While a definitive root cause could not be determined, it is possible that the implant might have encountered unintended forces.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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.H3, h4, h6: a device history record (dhr) review was conducted: part number: 04.033.973s, lot number: 2l80025, manufacturing site: bettlach, release to warehouse date: 19.Jan.2019, expiry date: 01.Jan.2029.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: 9 MM / TI CANN FRN / GT 420MM / LEFT - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9907551
• Report Number: 2939274-2020-01640
• Device Sequence Number: 2732453
• Product Code: HSB
• UDI-Device Identifier: 10886982272362
• UDI-Public: (01)10886982272362
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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: 04.033.973S
• Device Catalogue Number: 04.033.973S
• Device Lot Number: 2L80025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 04/22/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RECON SCREWS; UNK - END CAPS; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention