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

Model Number	MDLR CNLTD TRIDRV DRVR
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
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
It was reported that during the case, the surgeon was drilling, and a pin fell out of the drill and onto the floor.No parts or pieces fell into the patient wound site.The event did not effect the surgical outcome.Product is available for return.
Additional Manufacturer Narrative
After review of additional information received the following sections, have been updated accordingly: h6: the broken tri-drive modular handle reported in case-2022-00006554 may have been due to numerous surgical uses and subsequent sterilization cycles, which resulted in the dowel pin disassociating from the assembly.
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.

• 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: 15743898
• Report Number: 1038671-2022-01417
• Device Sequence Number: 20593895
• Product Code: LXH
• UDI-Device Identifier: 10885862085313
• UDI-Public: 10885862085313
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 03/23/2026

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: 68106010
• 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: 10/07/2022
• Supplement Date Received by Manufacturer: 03/16/2023; 03/13/2026
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 03/22/2023; 03/23/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female