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

Model Number	BH, STRT LOCK, BRCH POST
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, during a procedure on a (b)(6) y/o male patient, the surgeon was broaching the canal with compaction broaches for the alteon ha.He broached to a size 10 and was unable to remove the broach.Removal of the broach from the femoral canal took place over an approx 10 minute time frame with no reported effects to the patient.The broach handle strike plate broke free from the broach handle.Another broach handle was attached and eventually the surgeon was able to remove the broach.Patient was last known to be in stable condition following the event.The device will be returned for evaluation.
Additional Manufacturer Narrative
The evaluation noted that revision reported was likely the result of the strike plate experiencing impaction forces during repeat surgical use which led to crack initiation, propagation, and ultimate failure of the weld.The most probable root cause associated with the reported event of " broken" is associated with a partial or full-thickness crack in the device materials.

• 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
• MDR Report Key: 11769872
• Report Number: 1038671-2021-00211
• Device Sequence Number: 19714741
• Product Code: LXH
• UDI-Device Identifier: 10885862267122
• UDI-Public: 10885862267122
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2021

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 Model Number: BH, STRT LOCK, BRCH POST
• Device Catalogue Number: 01-003-02-0003
• Device Lot Number: 108908011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 05/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR