MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; MDLR CNLTD TRIDRV DRVR

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	11/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during loading a drill bit at the back table, the spring mechanism inside detached as we were trying to load a drill on it.No parts or pieces fell into the patient.There was a small delay to wait for another tray which had another drive handle inside.The (b)(6) male patient was not effected.Patient was last known to be in stable condition following the event.The device is to be returned.
Additional Manufacturer Narrative
Pending evaluation.
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during loading a drill bit at the back table, the spring mechanism inside detached as we were trying to load a drill on it.No parts or pieces fell into the patient.There was a small delay to wait for another tray which had another drive handle inside.The (b)(6) male patient was not effected.Patient was last known to be in stable condition following the event.The device is to be returned.
Additional Manufacturer Narrative
Section h10: d4: lot number: 128491030.H3: the broken 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, which led to the disassembly of the spring when attempting to lead the drill on the device.

• Brand Name: EQUINOXE
• Common Device Name: MDLR CNLTD TRIDRV DRVR
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 12955015
• Report Number: 1038671-2021-00675
• Device Sequence Number: 4292389
• Product Code: LXH
• UDI-Device Identifier: 10885862085313
• UDI-Public: 10885862085313
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

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
• Device Lot Number: 128491030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 01/13/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male