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

Catalog Number	301-05-01
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported that during surgical use, piece of the broach handle broke off during trial broach inspection.A piece was seen by surgeon right away.When it fell off, surgeon put the piece aside without any issues at all.This was simply a broken instrument during use in surgery that did not have any adverse effect.Broken pieces were located and put aside right away so not problem at all.No problem, no issues, no delay, no adverse effect, no concern of any kind as all was ok.No patient information, not implant related as only a piece of the broach handle instrument broke off and it was put aside as no issues to the surgery at all.No patient information.Photos attached.Device is returning.
Additional Manufacturer Narrative
H3: the broken instrument reported was likely the result of the small bridge area thickness of 0.035 inches, coupled with movement of the pull release shaft (301-200-01) during impaction, which likely made the bridge area susceptible to failure.*the following sections have corrected information: h6: medical device problem code, component code.

• Brand Name: ERGO BROACH HANDLE
• 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: 16808266
• Report Number: 1038671-2023-00822
• Device Sequence Number: 12260078
• Product Code: LXH
• UDI-Device Identifier: 10885862530479
• UDI-Public: 10885862530479
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 12/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 301-05-01
• 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: 04/03/2023
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 12/12/2024
• 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
• Patient Sex: Unknown