MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/125 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 456.314S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); No Code Available (3191)

Event Date 02/05/2020

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.(b)(4).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 lot: manufacturing location: (b)(4).Manufacturing date: 07-aug-2015.Expiration date: 30-jun-2024.Part number: 456.314s, 10mm/125 deg ti cann troch fixation nail 170mm ¿ sterile.Lot number: 9872225 (sterile).Lot quantity: 6.Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final, ns054633 rev e met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev j was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 11655 supplied by ethicon (abq) 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 part(s) reviewed: part number: 456.314.3, lock driver tfb.Lot number: 7947248.Lot quantity: 200.Work order traveler met all inspection acceptance criteria.Inspection sheet, inspect dimensional / final, 456+fi314-3 rev h met all inspection acceptance criteria.Part number: 456.314.2: 125 degree lock prong tfn.Lot number: 9836686.Lot quantity: 49.Work order traveler met all inspection acceptance criteria.Inspection sheet, in-process acceptance, op045442 rev b met all inspection acceptance criteria.Inspection sheet, ns043901 rev d met all inspection acceptance criteria.Part number: 21069, tialnbri18.00.Lot number: 7945619.Lot quantity: 3,356 lbs.Certificate of test supplied by ati specialty materials dated 13-feb-2015 was not a legible scanned copy and could not be thoroughly reviewed.Lot summary report dated 03-mar-2015 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Device history review: 17-feb-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 Description

It was reported that on (b)(6) 2020, the surgeon removed a trochanteric fixation nail (tfn) because the patient had arthritis.The tfn nail, titanium (ti) helical blade, titanium (ti) locking screw and end cap were removed with no issues.There was no surgical delay.Procedure successfully completed.No patient consequence.This complaint involves four (4) devices.This is 1 of 4 for report (b)(4).

• Brand Name: 10MM/125 DEG TI CANN TROCH FIXATION NAIL 170MM-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 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9762612
• MDR Text Key: 192016773
• Report Number: 2939274-2020-01066
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982226891
• UDI-Public: (01)10886982226891
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 456.314S
• Device Catalogue Number: 456.314S
• Device Lot Number: 987225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR