MAUDE Adverse Event Report: EXACTECH, INC. MDLR BROACH HNDL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	301-03-01
Medical Device Problem Codes	Break (1069); Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during surgical use, the metal bar in the broach handle fell out when impacting.The case was delayed by 10-15 minutes due to x-ray to see if the bar was inside the patient.Per the rep, the metal bar was not in the patient.The patient was last known to be in stable condition following the event.No other patient information/medical history provided.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
H3: the broken modular broach handle reported may have been the result of a fractured weld, improper disassembly during cleaning, excessive impaction forces during surgery, an incomplete weld, improper finishing during the manufacturing step, or any combination of these possibilities.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: h2 and h6.As determined by (b)(4), the broken modular broach handle reported may have been the result of a fractured weld, improper disassembly during cleaning, excessive impaction forces during surgery, an incomplete weld, improper finishing during the manufacturing step, or any combination of these possibilities.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: MDLR BROACH HNDL
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16312998
• Report Number: 1038671-2023-00116
• Device Sequence Number: 6278977
• Product Code: LXH
• UDI-Device Identifier: 10885862079619
• UDI-Public: 10885862079619
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2025

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: 301-03-01
• Device Catalogue Number: 301-03-01
• Device Lot Number: 288708001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 05/26/2023; 04/01/2025
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 06/06/2023; 04/03/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Male