MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 440MM/LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.165S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 an unknown date, the patient underwent removal of implants due to broken trochanteric femoral nailing advanced (tfna) nail.Originally the patient was implanted with tfna nail, blade, and bolt on an unknown date.All implants were removed and converted to blade plate.The procedure was completed successfully.It was unknown if there was a surgical delay during revision.There was no patient consequence reported.Concomitant devices reported: tfna helical blade (part# 04.038.410, lot# unknown, quantity 1).Unknown locking screw (part# unknown, lot# unknown, quantity 1).Unknown wire (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This is 1 of 1 for report (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, h4, h6: 11mm/130 deg ti cann tfna 400mm/left ¿ sterile was received at us cq.Upon visual inspection at cq, it is observed that the nail got broken at head part near helical screw hole.There were few discolored spots and scratches found on the surface of the device.The rest of the device shows normal wear which would not contribute to the complaint condition.Thus, the complaint is being confirmed.Visual inspection, dimensional inspection, and document specification review of the received device was performed at cq.The complaint is being confirmed as the nail got broken at head part near helical screw hole.A definitive root cause could not be determined for the reported problem, it is possible that the device 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.Device history lot manufacturing location: monument manufacturing date: 19-sep-2017, expiration date: 31-aug-2027, part number: 04.037.165s, 11mm/130 deg ti cann tfna 440mm / left ¿ sterile, lot number: h454123 (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: l519000, part number: 04.037.912.4, wave spring, shim ended bp55, lot number: h316262, part number: 04.037.912.3, tfna lock drive bp58, lot number: h435641, part number: 21127, timoagri16.00 bp80, lot number: h249238.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 440MM/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: 9849746
• Report Number: 2939274-2020-01329
• Device Sequence Number: 19017824
• Product Code: HSB
• UDI-Device Identifier: 10886982096739
• UDI-Public: (01)10886982096739
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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: 04.037.165S
• Device Catalogue Number: 04.037.165S
• Device Lot Number: H454123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 04/07/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11MM/130 DEG TI CANN TFNA 440MM/LEFT - STERILE; TFNA FENESTRATED HELICAL BLADE 110MM; UNK - CABLE/WIRE: ORTHOPAEDIC CABLE; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR