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

Catalog Number	315-25-00
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during a procedure, the tri drive spring became jammed when switching in between reamer sizes.In an effort to ¿unjam¿ the tri drive the spring is no longer connected to the instrument.The patient was checked for debris, confirmed with surgical staff and continued on with the delay to the joint replacement.No one was harmed and the patient is last known to be in stable condition.Device to be returned.
Additional Manufacturer Narrative
Section h10: h3: the disassembled tri-driver reported was likely the result of the retaining ring responsible for maintaining assembly of the sleeve on the tre-driver shaft becoming deformed as a result of obstruction of the tri-driver while reaming.Section h11: the following sections have corrected information: h4: lot number: 259375026.

• 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: 12258535
• Report Number: 1038671-2021-00366
• Device Sequence Number: 19730365
• 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): 08/12/2021

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 Catalogue Number: 315-25-00
• Device Lot Number: 259375026
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 08/12/2021
• 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