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

Model Number	A+ BROACH HANDLE RIGHT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during impaction, the spring on the broach handle was broken by surgeon.This situation came to no surprise because this has happened to surgeon on numerous occasions using a plus sized mallet while broach femur.This incident caused no delay, the surgical site was confirmed clean by surgeon and the procedure carried on as planned.Patient is stable condition.The device will be return.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, during impaction, the spring on the broach handle was broken by surgeon.This situation came to no surprise because this has happened to surgeon on numerous occasions using a plus sized mallet while broach femur.This incident caused no delay, the surgical site was confirmed clean by surgeon and the procedure carried on as planned.Patient is stable condition.The device will be return.
Additional Manufacturer Narrative
After further review of additional information received the following sections d10, g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the broken instrument reported 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.The most probable root cause associated with the reported event of "broken / non-functional" is associated with a partial or full-thickness crack in the device materials.

• Brand Name: A+ BROACH HANDLE RIGHT
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 13500541
• Report Number: 1038671-2022-00192
• Device Sequence Number: 5353622
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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 RIGHT
• Device Catalogue Number: 167-02-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown