MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 440MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.164S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Malunion of Bone (4529)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: may 23, 2018; expiration date: april 30, 2028.Part number: 04.037.164s, 11mm/130 deg ti cann tfna 440mm / right ¿ sterile.Lot number: h619496 (sterile).Work order traveler met all inspection acceptance criteria.Nr-0096155 was initiated due to op #120, inspect dimensional, not filled out on the inspection sheet.The disposition of the nr was ¿rework¿ by inspecting the lot per the inspection sheet requirements for all affected features.The lot was determined to be acceptable after these inspections and was released from hold.Inspection sheet, in process / inspect dimensional / final, ns071295 rev c met all inspection acceptance criteria after the rework noted.Inspection sheet, tfna assembly inspection, ns067861 rev b met all inspection acceptance criteria.Packaging label log (pll) lppf rev d was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 15061 supplied by ees (albuquerque) 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: l827051; purchased finished goods traveler met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended bp55; lot number: h529597.Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection ns062851 rev b met all inspection acceptance criteria.Material certification and certificate of conformance and quality history card supplied by smalley dated 06-apr-2018 were reviewed and determined to be conforming.Part number: 04.037.912.3, tfna lock drive bp58.Lot number: h623096.Work order traveler met all inspection acceptance criteria.Inspection sheet ns062925 rev e met all inspection acceptance criteria.Part number: 21127, timoagri16.00 bp80; lot number: h441264.Certified test report supplied by perryman company dated 18-jul-2017 and certificate of test supplied to perryman by howmet castings dated 16-dec-2015 were reviewed and determined to be conforming.Lot summary report dated 29-aug-2017 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.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 underwent revision surgery for proximal femur fracture due to malunion/nonunion.Tfna was removed and a smith and nephew nail was then implanted in place along with a 4.5mm proximal femur hook plate.The date of the original implant was unknown.There was no surgical delay reported.The procedure was successfully completed.This report is for one (1) 11mm/130 deg ti cann tfna 440mm/right - sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 11MM/130 DEG TI CANN TFNA 440MM/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: 10905211
• Report Number: 2939274-2020-05314
• Device Sequence Number: 1429083
• Product Code: HSB
• UDI-Device Identifier: 10886982096722
• UDI-Public: (01)10886982096722
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• 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): 10/30/2020

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: 04.037.164S
• Device Catalogue Number: 04.037.164S
• Device Lot Number: H619496
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/25/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention