MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE; ROD, FIXATION ,INTRAMEDULLARY

Model Number	04.037.059S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event year reported as 2018, exact date of postoperative nail breakage is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is synthes sales consultant.A review of the device history records has been requested.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 a patient underwent a hardware removal on (b)(6) 2018.The devices removed were a trochanteric fixation nail advanced (tfna) nail, unknown helical blade, and two (2) unknown locking screws.It was stated that approximately 4 days prior to the event, the patient presented to the emergency room (er) with progressing lateral hip pain.X-rays revealed a broken tfna nail at the blade nail junction.The patient's original implant procedure was done on (b)(6) 2018 due to subtrochanteric fracture.The fracture was repaired using a synthes proximal femur plate and screws.Procedure and patient outcome are unknown.Concomitant devices reported: helical blade (part# unknown, lot# unknown, quantity 1); locking screws (part# unknown, lot# unknown, quantity 2).This report is for one (1) tfna nail.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Device history lot manufacturing location: (b)(4), manufacturing date: 02-jun-2017, expiration date: 30-apr-2027, part number: 04.037.059s, 10mm/130 deg ti cann tfna 380mm/left ¿ sterile, lot number: h377821 (sterile).This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component parts reviewed: part number: 04.037.942.2, lock prong 130 degree, tfna, bp55, lot number: l367699, lot quantity: (b)(4), purchased finished goods traveler met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended, bp55, lot number: h249496, part number: 04.037.912.3, tfna lock drive, bp58, lot number: h369493, part number:21127, timoagri16.00, bp80, lot number: h210699, device history review: 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: 10MM/130 DEG TI CANN TFNA 380MM/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: 8188637
• Report Number: 2939274-2018-55517
• Device Sequence Number: 2266885
• Product Code: HSB
• UDI-Device Identifier: 10886982096159
• UDI-Public: (01)10886982096159
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

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: 04.037.059S
• Device Catalogue Number: 04.037.059S
• Device Lot Number: H377821
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 12/25/2018
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 12/26/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE EVENT DESCRIPTION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR