MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 380MM/RIGHT-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.258S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date is unknown date in 2020.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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: part number: 04.037.258s, 12mm/130 deg ti cann tfna 380mm/right- sterile.Lot number: 15l1654 (sterile).Manufacturing location: (b)(4).Manufacturing date: 29-aug-2019.Expiration date: 31-jul-2029.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.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 16577 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 part(s) reviewed: part number: 04.037.912.3, tfna lock drive.Lot number: 12l0288.Lot quantity: (b)(4).One piece was scrapped in cell at op #100, pack/label, after being dropped.Production order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended.Lot number: h795861.Lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card received from smalley dated 19-feb-2019 were reviewed and determined to be conforming.Part number: 04.037.942.2, lock prong, 130 degree tfna.Lot number: 5l21087.Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Part number: 21127, timoagri16.00.Lot number: 10l0917.Lot quantity: 916 lbs.Inspection instruction met all inspection acceptance criteria.Certified test report supplied by perryman company dated 21-may-2019 was reviewed and determined to be conforming.Lot summary report dated 13-jun-2019 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.This lot met all dimensional, visual 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 and revision surgery due to a broken proximal femoral nailing system (tfna) nail.The patient fell and the implant broke on an unknown date.The broken proximal femoral nailing system (tfna) nail was replaced with another new proximal femoral nailing system (tfna).The procedure outcome and patient status are unknown.The original hardware was implanted on (b)(6) 2020.Concomitant device reported: tfna fenestrated screw (part# 04.038.190s, lot# unknown, quantity# 1).Unknown locking screw (part# unknown, lot# unknown, quantity# unknown).This is report 1 of 1 for (b)(4).

• Brand Name: 12MM/130 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: 10393082
• Report Number: 2939274-2020-03474
• Device Sequence Number: 16572108
• Product Code: HSB
• UDI-Device Identifier: 10886982097385
• UDI-Public: (01)10886982097385
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/20/2020

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: 04.037.258S
• Device Catalogue Number: 04.037.258S
• Device Lot Number: 15L1654
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/11/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 49