MAUDE Adverse Event Report: EXACTECH, INC. A+ BROACH HANDLE LEFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	A+ BROACH HANDLE LEFT
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The broken device reported was likely the result of wear due to years of surgical use and/or manipulating the retaining ring possibly during cleaning, which led to the disassembly of the broach locking pin, lever, lever pivot pin, retaining ring and compression spring.The design has been updated to replace the lever pivot pin and stainless-steel retaining ring with a lever pivot rivet to improve the robustness of the design.
Event or Problem Description
It was reported that the springs on the locking mechanism of the broach handle have broken.This has happened over time by heavy strikes with the mallet and careless behavior in central sterile.The springs and locking mechanisms are damaged on the handles.No other information provided.

• Brand Name: A+ BROACH HANDLE LEFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15752762
• Report Number: 1038671-2022-01419
• Device Sequence Number: 2859061
• Product Code: LXH
• UDI-Device Identifier: 10885862036018
• UDI-Public: 10885862036018
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A+ BROACH HANDLE LEFT
• Device Catalogue Number: 167-01-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown