MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9 MM / TI CANN FRN / GT 360MM / RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.033.966S
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
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) 2020, the patient underwent revision surgery due to broken femoral recon nail (frn).Originally, the patient had an implantation on an unknown date.Post-surgery after a month, the leg was not healed.When the nail broke and the leg was still broken.The implant was successfully explanted without any issue.There was no surgical delay.The patient was stable after the procedure.Procedure and patient outcome are unknown.Concomitant devices reported: unknown locking screws (part # unknown, lot # unknown, quantity # unknown), unknown recon screws (part # unknown, lot # unknown, quantity# unknown), unknown end cap (part # unknown, lot # unknown, quantity 1).This report is for one (1) 9 mm / ti cann frn / gt 360mm / right - 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.E3: reporter is a synthes employee.H3, h4, h6: part: 04.033.966s.Lot: 2l79993.Manufacturing site: bettlach.Release to warehouse date: january 22, 2019.Expiry date: december 31, 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the 9 mm / ti cann frn / gt 360mm / right - sterile was received at us customer quality (cq).The device was broken at its first locking hole by the distal tip of the device.The break was clean, and the fragment was returned.No other defects were identified with the device.The received condition was consistent with the complaint condition thus, the complaint was confirmed.Dimensional inspection: cannulation diameter = conforming.Outer diameter at fracture site = conforming.Document/specification review: drawing(s) reviewed: current & manufactured revisions.Conclusion: the overall complaint was confirmed for the received 9 mm / ti cann frn / gt 360mm / right - sterile.Although no definitive root-cause can be determined, its possible the device encountered unintended forces while implanted in the patient.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.H6: code 3191 used to capture required surgical intervention and device removal.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 360MM / RIGHT - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9687296
• Report Number: 2939274-2020-00736
• Device Sequence Number: 16997589
• Product Code: HSB
• UDI-Device Identifier: 10886982272225
• UDI-Public: (01)10886982272225
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/16/2020

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: 04.033.966S
• Device Catalogue Number: 04.033.966S
• Device Lot Number: 2L79993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 03/06/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - END CAPS; UNK - SCREWS: LOCKING; UNKNOWN RECON SCREWS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR