MAUDE Adverse Event Report: EXACTECH, INC. BH, STRT LOCK, BRCH POST; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	01-003-02-0003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported that the strike plate attached to the broach handle broke off when trying to back slap the broach and handle out of the patient.The 2nd one in a month, he has had broken.No parts or pieces fell into the wound.There was no surgical delay.Patient was last known to be in stable condition following the event.Device is returning.
Additional Manufacturer Narrative
Section h10: (h3) the broken device reported was likely the result of numerous impaction forces from repeat surgical use, which led to crack initiation, propagation, and ultimate failure of the body-strike plate weld interface.Section h11: the following sections have corrected information: (h6) component code: 3195, weld.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that the event did not involve a death or serious injury nor would be likely to cause or contribute to a death or serious injury if the reported malfunction were to recur.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.

• Brand Name: BH, STRT LOCK, BRCH POST
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15087628
• Report Number: 1038671-2022-00831
• Device Sequence Number: 14427453
• Product Code: LXH
• UDI-Device Identifier: 10885862267122
• UDI-Public: 10885862267122
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• 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,Followup
• Report Date (Section B): 04/08/2026

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: 01-003-02-0003
• Device Catalogue Number: 01-003-02-0003
• Device Lot Number: 108908011
• 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: 07/12/2022
• Supplement Date Received by Manufacturer: 01/10/2023; 04/08/2026
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 01/26/2023; 04/08/2026
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Patient Sex: Unknown