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

Model Number	456.424S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hwc.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient underwent revision surgery due to a broken unknown trochanteric fixation nail system (tfn) nail and an unknown distal interlocking screw on (b)(6) 2019.Originally, the patient was implanted with the tfn in the right femur on an unknown date.The implants were successfully explanted and replaced with a tfn with helical blade.There was no reported surgical delay.The surgery was completed with no adverse consequence to the patient.Concomitant device reported: unknown tfn helical blade (part # unknown, lot # unknown, quantity# 1).This is report 1 of 2 for (b)(4).
Additional 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.A device history record (dhr) review was conducted: manufacturing location: monument.Manufacturing date: 16-aug-2013.Expiration date: 01-jul-2022.Part number: 456.424s, 11mm/130 deg ti cann troch fixation nail 440mm/right- sterile.Lot number: 7459142 (sterile).Lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.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: 456.314.3, lock driver tfn, bp55.Lot number: 7410463.Lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Part number: 456.315.2, 130 degree lock prong tfn, bp58.Lot number: 7422388.Lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Part number: 21069, tialnbri18.00, bp80.Lot number: 7399644.Lot quantity: 863 lbs.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.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.

• Brand Name: 11MM/130 DEG TI CANN TROCH FIXATION NAIL 440MM/RIGHT-STER
• 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: 9452583
• Report Number: 2939274-2019-62633
• Device Sequence Number: 3039833
• Product Code: HSB
• UDI-Device Identifier: 10886982227904
• UDI-Public: (01)10886982227904
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

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 Expiration Date: 07/01/2022
• Device Model Number: 456.424S
• Device Catalogue Number: 456.424S
• Device Lot Number: 7459142
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 12/16/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAIL HEAD ELEMENTS: TFN HELICAL BLADE
• Outcome Attributed to Adverse Event: Required Intervention