MAUDE Adverse Event Report: EXACTECH, INC. MDLR CNLTD TRIDRV DRVR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	315-25-00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ream and the mechanism at the bottom where it connects became loose and stopped working properly.It did not impact the case outcomes and pieces did not fall in to the wound site.
Additional Manufacturer Narrative
Pending evaluation.
Additional Manufacturer Narrative
Section h10: (h3) the disassembled tri-driver reported was likely the result of the retaining ring responsible for maintaining assembly of the sleeve on the tri-driver shaft becoming deformed as a result of the sleeve being held stationary while reaming or the sleeve being obstructed by soft tissue or bone.

• Brand Name: MDLR CNLTD TRIDRV DRVR
• 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: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16723183
• Report Number: 1038671-2023-00648
• Device Sequence Number: 7950350
• Product Code: LXH
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2026

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 Catalogue Number: 315-25-00
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 04/27/2023; 09/24/2026
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/17/2023; 09/24/2026
• 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
• Patient Sex: Unknown