MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.259S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Manufacturing location: (b)(4), manufacturing date: 03-oct-2019, expiration date: 3-aug-2029, part number: 04.037.259s, 12mm/130 deg ti cann tfna 380mm/left- sterile, lot number: 17p3674 (sterile), lot quantity: (b)(4).Production 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 (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn (b)(4) supplied by (b)(4) 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 part(s) reviewed: part number: 04.037.912.3, tfna lock drive, lot number: 16l4953, lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended, lot number: 10l4203, lot quantity: (b)(4).Production 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 19-sep-2019 were reviewed and determined to be conforming.Note: material certificate indicates the lot was supplied from (b)(4) lot number 2708390b but sample data sheets indicate lot number 2708390a.Data results were all acceptable.Part number: 04.037.942.2, lock prong, 130 degree tfna, lot number: 15l5529, lot quantity: (b)(4).One piece was scrapped in cell, edm prong, after a machine malfunction.Two pieces were scrapped in cell, final inspection, for the hex being too deep.Production order traveler met all inspection acceptance criteria apart from the three pieces noted.Inspection sheet, final inspection met all inspection acceptance criteria apart from the two pieces noted.Part number: 21127, timoagri16.00, lot number: 11l2711, lot quantity: (b)(4) "lbs." inspection instruction met all inspection acceptance criteria.Certificate of analysis supplied by (b)(4).Dated 31-may-2019 was reviewed and determined to be conforming.Lot summary report dated 25-jun-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.Product was not returned.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.(b)(4).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 that the trochanteric fixation nail advanced (tfna) system long nail broke.It is unknown when the issue was discovered.It is unknown if there were patient and procedure involvement.Concomitant devices: unk - screws: (part# unknown; lot# unknown; quantity: unknown), tfna fenestrated helical blade (part: 04.038.400; lot: unknown; quantity: (b)(4)).This report is for one (1) 12mm/130 deg ti cann tfna 380mm/left-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 12MM/130 DEG TI CANN TFNA 380MM/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: 10189889
• Report Number: 2939274-2020-02965
• Device Sequence Number: 908773
• Product Code: HSB
• UDI-Device Identifier: 10886982097392
• UDI-Public: 10886982097392
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2020

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: 04.037.259S
• Device Catalogue Number: 04.037.259S
• Device Lot Number: 17P3674
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 06/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention