MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 420MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.163S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) 2019, a patient underwent removal of proximal femoral nailing system (tfna) due to nonunion and delayed healing.The nail was broken at the lag screw junction.The lag screw was intact.The distal locking screw was broken.All hardware was removed.There were fragments generated from the broken device but it was removed easily.There was a medical intervention required to total hip insertion.The original implant was on (b)(6) 2019.There was no surgical delay.The procedure was successfully completed.There was no patient consequence.Concomitant device reported: tfna fenestrated screw (part# 04.038.195s, lot# h723308, quantity# 1).This report is for one (1) 11mm/130 deg ti cann tfna 420mm/left - 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.Device history lot manufacturing location: monument manufacturing date: 23-apr-2015 expiration date: 28-feb-2025 part number: 04.037.163s, 11mm/130 deg ti cann tfna 420mm/left- sterile lot number: 7961302 (sterile) this lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 04.037.942.2, lock prong, 130 degree tfna, bp55 lot number: 9243604 part number: 04.037.912.4, wave spring, shim ended, bp55 lot number: 7722159 part number: 04.037.912.3, tfna lock drive, bp58 lot number: 7870938 part number: 21127, timoagri16.00, bp80 lot number: 7568481 this lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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/130 DEG TI CANN TFNA 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: 8905554
• Report Number: 2939274-2019-59870
• Device Sequence Number: 2538341
• Product Code: HSB
• UDI-Device Identifier: 10886982096715
• UDI-Public: (01)10886982096715
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 07/22/2019

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 Expiration Date: 02/28/2025
• Device Model Number: 04.037.163S
• Device Catalogue Number: 04.037.163S
• Device Lot Number: 7961302
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 09/17/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFNA FENESTRATED SCREW 95MM - STERILE; TFNA FENESTRATED SCREW 95MM - STERILE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 99