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

Catalog Number	315-25-00
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.
Event or Problem Description
It was reported that during surgical use on a male patient, the surgeon was reaming the glenoid, the spring inside the tri drive head snapped, resulting in it no longer being able to hold onto/connect to the reamer.There was no evidence of inappropriate use.There was a spare so it did not impact the operation.No parts or pieces fell into the patient wound site.No surgical delay/prolongation.Unable to obtain x-rays.Device is returning.
Additional Manufacturer Narrative
Section h10: (h3) the broken cannulated 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.Section h11: *the following sections have corrected information: (h6) component code: 943, ring.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: d8, e2, e3, g1.The following sections were corrected: d4: lot number, g4: 510k, h6.The broken cannulated 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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g4:510k k042021, k093430 the broken cannulated 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.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 ct; gaiensville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17641445
• Report Number: 1038671-2023-02074
• Device Sequence Number: 5970676
• Product Code: LXH
• UDI-Device Identifier: 10885862085313
• UDI-Public: 10885862085313
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042021
• 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,Followup
• Report Date (Section B): 03/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 315-25-00
• Device Lot Number: 68107013
• 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: 08/08/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 03/06/2025; 03/06/2025
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 12/19/2023; 03/07/2025; 03/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Patient Sex: Male