MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/125 DEG TI CANN TFNA 380MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.128S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr: a device history record (dhr) review was conducted: manufacturing location: (b)(4).Manufacturing date: 28-jun-2019.Expiration date: 31-may-2029.Part number: 04.037.128s, 11mm/125 deg ti cann tfna 380mm/right- sterile.Lot number: 10l6256 (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.Scn 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: 04.037.912.2, lock prong, 125 degree tfna.Lot number: 4l09698.Lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended.Lot number: h794544.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.Lot number: h880093.Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheets met all inspection acceptance criteria.Part number: 21127, timoagri16.00.Lot number: h883875.Lot quantity: (b)(4).Certificate of analysis was reviewed and determined to be conforming.Lot summary report dated 19-apr-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.(b)(4).Device evaluated by mfr: 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) 2021, the patient arrived in the hospital with the trochanteric femoral nailing advanced (tfna) nail broken where the helical blade entered the nail.Initially on (b)(6) 2021, patient underwent surgery for a comminuted intertrochanteric proximal right femur fracture that was fixed with tfna.The patient was revised on (b)(6) 2021, with a 60 mm 9 hole 95 degree blade plate coupled with autograft that was harvested from the contralateral femur using a 12 mm reamer irrigator aspirator (ria).All the original hardware was removed without incident.The procedure was successfully completed.Patient outcome is reported as successful.This report is for one (1) 11mm/125 deg ti cann tfna 380mm/right - sterile.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 11MM/125 DEG TI CANN TFNA 380MM/RIGHT - 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: 11978109
• Report Number: 2939274-2021-02886
• Device Sequence Number: 3604884
• Product Code: HSB
• UDI-Device Identifier: 10886982096425
• UDI-Public: (01)10886982096425
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2021

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: 04.037.128S
• Device Catalogue Number: 04.037.128S
• Device Lot Number: 10L6256
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/10/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention