MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; A+ BROACH HANDLE RIGHT

Catalog Number	167-02-00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
Surgeon broke the spring in the handle during impaction.The patient was not affected.There was no harm to the patient.The case went on as planned with no issue.Patient was last known to be in stable condition following the event.Patient in stable condition and not affected.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation of the of the reported event noted that event was likely the result of years of surgical use under rigorous impact loading conditions, which resulted in a fractured latch pin subcomponent.The design has been updated.No information provided in the following section(s): a2, a3, a4, a5, b6, b7.The following section(s) have additional info: g4, g7, h1, h2, h3, and h7.

• Brand Name: EXACTECH
• Common Device Name: A+ BROACH HANDLE RIGHT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11036121
• Report Number: 1038671-2020-00655
• Device Sequence Number: 19091143
• Product Code: LXH
• UDI-Device Identifier: 10885862036025
• UDI-Public: 10885862036025
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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 Catalogue Number: 167-02-00
• Device Lot Number: 38022006
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other