MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.061S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Product was not returned.Based on the information available, it has been determined that no corrective and 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.A device history record (dhr) review was conducted: manufacturing location: (b)(4), manufacturing date: 02-aug-2019, expiration date: 30-jun-2029, part number: 04.037.061s, 10mm/130 deg ti cann tfna 400mm / left ¿ sterile, lot number: 12l7797 (sterile), lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.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, lot number: 5l00409, lot quantity: (b)(4), production order traveler met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended, lot number: h795846, lot quantity: (b)(4), work order traveler met all inspection acceptance criteria.Part number: 04.037.912.3, tfna lock drive, lot number: 3l45154, lot quantity: (b)(4).One piece was scrapped in cell, ultrasonic clean, after being dropped.Production order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheets met all inspection acceptance criteria.Part number: 21127, timoagri16.00 bp80, lot number: 3l28792, lot quantity: (b)(4) lbs.Inspection instruction met all inspection acceptance criteria.Certificate of analysis supplied by metalwerks inc.Dated 09-apr-2019 was reviewed and determined to be conforming.Lot summary report dated 17-may-2019 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.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.
Event or Problem Description
It was reported that on (b)(6) 2020, the patient underwent revision surgery due to a non-union of a sub-troch femur fracture that was originally treated with a long proximal femoral nailing system (tfna) on (b)(6) 2020.The patient recently complained of some leg pain and an x-ray revealed a non-union with a broken tfna long nail.The nail was broken at the helical blade insertion opening in the nail.The distal locking screw, tfna helical blade, broken proximal and distal piece of the tfna long nail were all removed uneventfully.The procedure proceeded and reduction and fixation were achieved with a locking compression plate (lcp) proximal femur hook and an assortment of locking screws and cortical screws.The procedure outcome is unknown.There was a patient consequence.Concomitant device reported: unknown distal locking screw (part#: unknown, lot#: unknown, quantity: 1); tfna fenestrated helical blade (part#: 04.038.375s, lot#: h754413, quantity: 1).This report is for one (1) 10mm/130 deg ti cann tfna 400mm/left - 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.H3, h4, h6: part 04.037.061s, lot 12l7797: manufacturing location: monument.Manufacturing date: august 02, 2019.Expiration date: june 30, 2029.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 400MM/LEFT - 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: 10995840
• Report Number: 2939274-2020-05563
• Device Sequence Number: 791853
• Product Code: HSB
• UDI-Device Identifier: 10886982096173
• UDI-Public: (01)10886982096173
• 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: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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: 04.037.061S
• Device Catalogue Number: 04.037.061S
• Device Lot Number: 12L7797
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 12/12/2020
• Supplement Report FDA Received Date: 01/06/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFNA FENESTRATED HELICAL BLADE 75MM - STERILE; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR