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

Model Number	MDLR CNLTD TRIDRV DRVR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
While reaming the glenoid, the spring and collar from the handle broke off.Handle was replaced, all parts were retrieved.No adverse effects to the patient or the outcome of the case.Patient was last known to be in stable condition following the event.Device to be returned for evaluation.
Additional Manufacturer Narrative
Section h10: (h3) the disassembled tri-drive handle reported was likely the result of the retaining ring responsible for maintaining assembly of the sleeve on the modular cannulated tri-drive shaft becoming deformed as a result of obstruction of the tri-driver collar while reaming.

• Brand Name: EQUINOXE
• Common Device Name: MDLR CNLTD TRIDRV DRVR
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11985000
• Report Number: 1038671-2021-00291
• Device Sequence Number: 11806966
• Product Code: LXH
• UDI-Device Identifier: 10885862085313
• UDI-Public: 10885862085313
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: 322289001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention