MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 170MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.142S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.Device history lot: manufacturing location: (b)(4), manufacturing date: aug 21, 2018, expiration date: jul 31, 2028, part number: 04.037.142s, 11mm/130 deg ti cann tfna 170mm-sterile, lot number: h709840 (sterile), lot quantity: 6.Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final ns071292 rev d met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection ns067861 rev b met all inspection acceptance criteria.Packaging label log (pll) lpf rev d, lmd rev a was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 15397 supplied by (b)(4) (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 part(s) reviewed: part number: 04.037.942.2, lock prong, 130 degree tfna, bp55, lot number: l938618, lot quantity: 95.Purchased finished goods traveler met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended, bp55, lot number: h571492, lot quantity: 1,000.Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, ns062851 rev b met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card received from (b)(4) dated may 02, 2018 were reviewed and determined to be conforming.Part number: 04.037.912.3, tfna lock drive, bp58, lot number: h691898, lot quantity: 55.Twenty-five pieces were scrapped in cell at op #10, machine complete, for the counterbore being too deep.Work order traveler met all inspection acceptance criteria apart from the twenty-five pieces noted.Inspection sheet, ns062925 rev e met all inspection acceptance criteria.Part number: 21127, timoagri16.00, bp80, lot number: h676158, lot quantity: 810 lbs.Certified test report supplied by (b)(4) dated 24-may-2018 was reviewed and determined to be conforming.Lot summary report dated 21-jun-2018 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.Device history review: feb 25, 2020: dhr reviewed.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 on an unknown date that the patient underwent removal of a short trochanteric femoral nail (tfna) on (b)(6) 2020.The patient sustained a distal third femur fracture.All implants were successfully explanted without issue and the patient was revised with a stryker nail.No patient consequences reported.This complaint involves four (4) devices.This is 1 of 4 for report (b)(4).

• Brand Name: 11MM/130 DEG TI CANN TFNA 170MM - 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: 9824597
• Report Number: 2939274-2020-01243
• Device Sequence Number: 3068670
• Product Code: HSB
• UDI-Device Identifier: 10886982096548
• UDI-Public: (01)10886982096548
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/15/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.037.142S
• Device Catalogue Number: 04.037.142S
• Device Lot Number: H709840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2020
• Initial Report FDA Received Date: 03/12/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Weight: 56