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	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer? pending evaluation.
Event or Problem Description
Instrument broke final stages of reaming glenoid, noticed on back table the sleeve had come loose and was no longer holding the reamer effectively.All pieces retained.Swapped out for the tri-drive on the other set they have ¿ no patient impact.
Event or Problem Description
As reported, instrument broke final stages of reaming glenoid, noticed on back table the sleeve had come loose and was no longer holding the reamer effectively.All pieces retained.Swapped out for the tri-drive on the other set they have no patient impact.Device to be returned.
Additional Manufacturer Narrative
Lot number: 288708026.The disassembled 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 of the sleeve being obstructed by soft tissue or bone.Section h11: the following sections have corrected information: (b5) as reported, instrument broke final stages of reaming glenoid, noticed on back table the sleeve had come loose and was no longer holding the reamer effectively.All pieces retained.Swapped out for the tri-drive on the other set they have ¿ no patient impact.Device to be returned.

• 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: 12868415
• Report Number: 1038671-2021-00639
• Device Sequence Number: 17037082
• Product Code: LXH
• UDI-Device Identifier: 10885862085313
• UDI-Public: 10885862085313
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2021

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: 288708026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 12/30/2021
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown