MAUDE Adverse Event Report: ARTHREX, INC. ES¿ TROCH NAIL, LEFT, Ø11MMX42CMX130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	ES¿ TROCH NAIL, LEFT, Ø11MMX42CMX130°
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on 09/01/2022 by a sales representative via email that an 1058-425 trochanteric nail broke at the lag screw hole and had to be removed through a revision surgery.This was replaced with a new nail.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint is confirmed.One unpackaged 1058-425, batch number 201203 was received for investigation.Visual evaluation found that the es trochanteric nail left, had broken off at the distal end at the chamfer 120° hole.The cause remains undetermined.However, the most likely reasons are improper bone prep and misaligned insertion.

• Brand Name: ES¿ TROCH NAIL, LEFT, Ø11MMX42CMX130°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 15445796
• Report Number: 1220246-2022-05500
• Device Sequence Number: 12690197
• Product Code: HSB
• UDI-Device Identifier: 00848665015188
• UDI-Public: 00848665015188
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K021008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: ES¿ TROCH NAIL, LEFT, Ø11MMX42CMX130°
• Device Catalogue Number: 1058-425
• Device Lot Number: 201203
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown