MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM / TI CANN FRN / PF 400MM / RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.033.140S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 revision nailing procedure to remove the broken nail with a new nail implanted.The patient was first treated on (b)(6) 2018, the patient followed up with a broken nail.It is unknown if there was surgical delay.Procedure and patient outcome are unknown.Concomitant devices reported: locking screw (part/lot unknown, quantity 1), recon screw (part/lot unknown, quantity 1).This report is for a nail.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.A device history record (dhr) review was conducted: part: 04.033.140s, lot: l771253, manufacturing site: bettlach, release to warehouse date: 01.Mar.2018, expiry date: 30.Jan.2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The raw material was confirmed to be correct per the specification with no non-conformance noted.A product investigation was conducted.Visual inspection: the 11 mm/ti cannulated femoral recon nail/ piriformis fossa 400mm/right ¿ sterile (part # 04.033.140s, lot # l771253, mfg # 01-mar-2018) was received at us cq with the distal portion of the nail broken at the 3rd hole from the bottom.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional inspection: dimensional analysis was completed, the dimension close to the fracture site measured and is within specification based on relevant drawing.Document/specification review: the relevant drawing(s) was reviewed; conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 11MM / TI CANN FRN / PF 400MM / RIGHT - 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: 8617126
• Report Number: 2939274-2019-58120
• Device Sequence Number: 14008283
• Product Code: HSB
• UDI-Device Identifier: 10886982272454
• UDI-Public: (01)10886982272454
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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: 04.033.140S
• Device Catalogue Number: 04.033.140S
• Device Lot Number: L771253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Initial Date Received by Manufacturer: 04/17/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/11/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: LOCKING; UNKNOWN - SCREW RECON; UNK - SCREWS: LOCKING; UNKNOWN - SCREW RECON
• Outcome Attributed to Adverse Event: Required Intervention