MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 11MM/125 DEG TI CANN TFNA 360MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.037.127S

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Manufacturing location: (b)(4), manufacturing date: 09-jan-2019, expiration date: 30-nov-2028, part number: 04.037.127s, 11mm/125 deg ti cann tfna 360mm/left- sterile, lot number: h804038 (sterile), lot quantity: (b)(4).Work 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) lppf was reviewed and determined to be conforming packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.(b)(4) supplied by ethicon (b)(4) 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, bp55, lot number: 1l48289, lot quantity: (b)(4), purchased finished goods traveler met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended, bp55, lot number: h681028, 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 were reviewed and determined to be conforming.Part number: 04.037.912.3, tfna lock drive, bp58, lot number: h799592, lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, met all inspection acceptance criteria.Part number: 21127, timoagri16.00, bp80, lot number: h790427, lot quantity: (b)(4).Certified test report was reviewed and determined to be conforming.Lot summary report met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.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 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 Description

It was reported that on (b)(6) 2021 the patient underwent a removal surgery of trochanteric fixation nail-advanced (tfna) nail due to cracked at lag screw/ nail junction and transition to total hip arthroplasty.All tfna implants were removed.The patient was than revised to a total hip arthroplasty.The original date of the surgery was on (b)(6) 2020.Concomitant device reported: femoral neck screws, perforated, sterile (part: 04.038.205s; lot: 12l5293; quantity:1), locking screws (part: 04.005.526; lot: unknown; quantity: 1), locking screw (part: 04.005.528s; lot: unknown; quantity: 1).This report is for one (1) 11mm/125 deg ti cann tfna 360mm/left - sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 11MM/125 DEG TI CANN TFNA 360MM/LEFT - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12529210
• MDR Text Key: 273997875
• Report Number: 3006356043-2021-00005
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982096418
• UDI-Public: 10886982096418
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.037.127S
• Device Catalogue Number: 04.037.127S
• Device Lot Number: H804038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 99