MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 420MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.062S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted approximately one (1) year ago.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: manufacturing location: (b)(4).Manufacturing date: 20-sep-2016.Expiration date: 31-aug-2026.Part number: 04.037.062s, 10mm/130 deg ti cann tfna 420mm / right ¿ sterile.Lot number: h190869 (sterile).Lot quantity: 3.One piece was scrapped in cell, gundrill, for a failed runout dimension.The five remaining pieces passed this inspection; however, an uneven wall thickness could potentially contribute to the reported complaint condition.One piece was scrapped in cell, mill distal holes, for a length dimension that failed the gage.The remaining 4 pieces were 100% inspected and determined to be acceptable for this feature.One piece was scrapped in cell at op, qa final inspect, for an unacceptable surface finish.This lot was processed under planned nr.Work order traveler met all inspection acceptance criteria apart from the three pieces noted.Inspection sheet, in-process / inspect dimensional / final met all inspection acceptance criteria apart from the three pieces noted.This lot met all dimensional, visual, sterilization and packaging criteria at the time of release but issues were documented during the manufacture that potentially could have contributed to this complaint condition.Component parts reviewed: part number: 04.037.942.2, lock prong, 130 degree, tfna, bp55, lot number: l048002, 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: h089442, lot quantity: (b)(4): work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Material certification and certificate of conformance and quality history card were reviewed and determined to be conforming.Part number: 04.037.912.3, tfna lock drive, bp58, lot number: h160412, lot quantity: (b)(4): work order traveler met all inspection acceptance criteria.Part number: 21127, timoagri16.00, bp80, lot number: h089199, lot quantity: 2,722 lbs.: certificate of analysis was reviewed and determined to be conforming.Lot summary report met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.This lot met all dimensional, visual, sterilization and packaging criteria but issues were documented during manufacture that potentially could have contributed to this complaint condition.(b)(4).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 on (b)(6) 2019, the patient underwent revision surgery due to nonunion of the right femur with a broken trochanteric femoral nail advanced (tfna) nail.Hardware was implanted approximately a year ago.The patient was revised with an angle blade plate and bone grafting.Surgery was completed successfully.Patient outcome was unknown.Concomitant device reported: tfna screw (part # 04.038.100, lot#7959062, quantity # 1); unknown distal 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).

• Brand Name: 10MM/130 DEG TI CANN TFNA 420MM/RIGHT - 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: 8637641
• Report Number: 2939274-2019-58226
• Device Sequence Number: 1858373
• Product Code: HSB
• UDI-Device Identifier: 10886982096180
• UDI-Public: (01)10886982096180
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/24/2019

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: 08/31/2026
• Device Model Number: 04.037.062S
• Device Catalogue Number: 04.037.062S
• Device Lot Number: H190869
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/23/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFNA SCREW 100MM; UNK - SCREWS: NAIL DISTAL LOCKING
• Outcome Attributed to Adverse Event: Required Intervention