MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 340MM/LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.155S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient underwent a revision surgery on (b)(6) 2018, due to a broken trochanteric fixation nail-advanced (tfna) long nail and delayed healing.The patient was originally implanted with the tfn-a nail, helical blade, and distal locking screw on (b)(6) 2017.The broken tfna nail was removed smoothly and disposed of.The revision surgery was completed using the same size tfn-a nail.The surgery was successfully completed with no delay.Patient outcome was not reported.Concomitant devices reported: unknown helical blade (part #: unknown, lot #: unknown, quantity: 1), unknown distal locking screw (part #: unknown, lot #: unknown, quantity: 1).This is report 1 of 1 for (b)(4).
Event or Problem Description
Further it was reported that there were no fragments generated and the broken tfna nail was removed smoothly and was disposed of, other hardware was unaffected.
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.Manufacturing location: monument, manufacturing date: 30-apr-2015, expiration date: 31-mar-2025, part number: 04.037.155s, 11mm/130 deg ti cann tfna 340mm/left- sterile, lot number: 7992421 (sterile), lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process/inspect dimensional/final met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev b was reviewed and determined to be conforming.Packaging bom was reviewed and all components issued met current defined requirements.Scn supplied by ethicon (abq) was reviewed and determined to be conforming.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 parts reviewed: 04.037.942.2, lock prong, 130 degree tfna, bp55 lot number: 9290299, lot quantity: (b)(4): work order traveler met all inspection acceptance criteria.04.037.912.4, wave spring, shim ended, bp55 lot number: 7722172, lot quantity: (b)(4): work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card received from (b)(4) dated 08-oct-2014 were reviewed and determined to be conforming.04.037.912.3, tfna lock drive, bp58 lot number: 7925948, lot quantity: (b)(4): work order traveler met all inspection acceptance criteria.Inspection sheet, ns062925 rev d met all inspection acceptance criteria.21127, timoagri16.00, bp80 lot number: 7720302, lot quantity: (b)(4): certified test report received from (b)(4) dated 17-apr-2014 and certificate of test received from howmet castings dated 26-sep-2013 were reviewed and determined to be conforming.Lot summary report dated 16-jun-2014 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.A review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No product was returned; the investigation was performed based on the received medical images.Upon review of the medical images, it can be confirmed that the reported nail is broken through the proximal locking hole.The cause for the break is not able to be determined.No manufacturing defects were identified upon review of the manufacturing records.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.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 340MM/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: 7889279
• Report Number: 2939274-2018-53846
• Device Sequence Number: 11389754
• Product Code: HSB
• UDI-Device Identifier: 10886982096630
• UDI-Public: (01)10886982096630
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2018

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 Expiration Date: 03/31/2025
• Device Model Number: 04.037.155S
• Device Catalogue Number: 04.037.155S
• Device Lot Number: 7992421
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 10/09/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE EVENT DESCRIPTION; SEE EVENT DESCRIPTION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR