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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during an initial procedure on a male patient, the surgeon was using the tri-driver to ream the glenoid and ¿the collar from the tri drive modular handle sprung off¿ and the reamer fell with it.The spring was broken, and we were unable to fix the collar.The collar and reamer fell into the patient.The surgeon was able to remove both parts that fell into the open wound.Delay was due to the reamer breaking, having to get out the two products that landed in the open wound, open a new tray and put the new driver onto power to continue with the procedure.Patient had no implants prior to the procedure that i know about.Patient was last known to be in stable condition following the event.Device to be returned.
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 holding the sleeve stationary 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: 11292345
• Report Number: 1038671-2021-00026
• Device Sequence Number: 3500153
• Product Code: LXH
• UDI-Device Identifier: 10885862085313
• UDI-Public: 10885862085313
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/13/2021

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: 145103001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 05/13/2021
• 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