MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.026S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
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.(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 history lot: manufacturing location: (b)(4), manufacturing date: april 30, 2019, expiration date: march 31, 2029, part number: 04.037.026s, 10mm/125 deg ti cann tfna 360mm/right¿ sterile, lot number: h877978 (sterile).Production and work order travelers 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 (b)(4) supplied by (b)(4) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterilization 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: part number: 04.037.912.2, lock prong 125 degree, tfna, bp55, lot number: 2l35966, purchased finished goods traveler met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended, bp55, lot number: h761714.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 received from smalley dated november 20, 2018 were reviewed and determined to be conforming.Part number: 04.037.912.3, tfna lock drive, bp58, lot number: h845553.Work order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part number: 21127, timoagri16.00, bp80, lot number: h856458.Certified test report supplied by (b)(4).Dated feb 21, 2019 was reviewed and determined to be conforming.Lot summary report dated march 15, 2019 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history review: july 31, 2020: dhr reviewed by: mschoenfeld.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 a removal of a broken tfna nail.It was broken at the opening of the helical blade.Procedure outcome and patient status were unknown.There is no further information available.Concomitant device reported: helical blade (part # 04.038.385s, lot # 691694, quantity 1), unknown locking screw (part # unknown, lot # unknown, quantity unknown).This report is for one (1) 10mm/125 deg ti cann tfna 360mm/right - sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 10MM/125 DEG TI CANN TFNA 360MM/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: 10413287
• Report Number: 2939274-2020-03553
• Device Sequence Number: 19444415
• Product Code: HSB
• UDI-Device Identifier: 10886982095848
• UDI-Public: (01)10886982095848
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.037.026S
• Device Catalogue Number: 04.037.026S
• Device Lot Number: H877978
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/17/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFNA FENESTRATED HELICAL BLADE 85MM - STERILE; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR