MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/125 DEG TI CANN TFNA 380MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.228S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event occurred on an unknown date in 2020.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.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 history lot: manufacturing location: (b)(4).Manufacturing date: jun 14, 2019.Expiration date: may 31, 2029.Part number: 04.037.228s, 12mm/125 deg ti cann tfna 380mm/right - sterile.Lot number: 3l42264 (sterile).One piece was scrapped in cell at op #30, gundrill, for a cannulation runout failure.The remainder of the lot was 100% inspected for this feature and determined to be acceptable.Production order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, in process / inspect dimensional / final, ns071305 rev f met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, tfna assembly inspection, ns067861 rev b met all inspection acceptance criteria.Packaging label log (pll) lppf rev d, lmd rev a was reviewed and determined to be conforming.Scn 16351 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: component parts were not reviewed because the reported complaint condition of ¿removal due to non-union¿ does not indicate breakage or failure of any component part, therefore, dhr review of the raw material(s) would not be relevant to the reported condition.Device history review: 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.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) 2020, the patient had a proximal femur fracture that was treated with a trochanteric fixation nail advanced (tfna) on (b)(6) 2020, and the patient failed to heal.The surgeon decided to convert the patient to a total hip replacement surgery.Removal of the tfna was required to proceed with the desired procedure due to non-union.Procedure outcome is unknown.There was patient consequence.This report is for one (1) 12mm/125 deg ti cann tfna 380mm/right - sterile.This is report 1 of 3 for (b)(4).

• Brand Name: 12MM/125 DEG TI CANN TFNA 380MM/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: 11214576
• Report Number: 2939274-2021-00400
• Device Sequence Number: 2915030
• Product Code: HSB
• UDI-Device Identifier: 10886982097149
• UDI-Public: 10886982097149
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/24/2020

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: 04.037.228S
• Device Catalogue Number: 04.037.228S
• Device Lot Number: 3L42264
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/24/2020
• Initial Report FDA Received Date: 01/22/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM; TFNA FENESTRATED SCREW 90MM
• Outcome Attributed to Adverse Event: Required Intervention