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

Model Number	MDLR CNLTD TRIDRV DRVR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgical use the device broke during reaming.No fragments, parts or pieces fell into the patient.All pieces were accounted for.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After review of additional information received the following sections, have been updated accordingly: h6: 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.The operative technique was updated to warn users against holding the sleeve of the tri- driver stationary while reaming.
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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• 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 66 court; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 3523771140
• MDR Report Key: 15756383
• Report Number: 1038671-2022-01428
• Device Sequence Number: 6675870
• Product Code: LXH
• UDI-Device Identifier: 10885862085313
• UDI-Public: 10885862085313
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 03/27/2026

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: MDLR CNLTD TRIDRV DRVR
• Device Catalogue Number: 315-25-00
• Device Lot Number: 47364013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 02/08/2023; 03/24/2026
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 03/06/2023; 03/30/2026
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male