MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; MDLR PRM RMR XLG PLT TIP

Catalog Number 315-25-15

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, the surgeon was reaming the glenoid, which was a very large glenoid, and the reamer caught a tip of bone while being run at full speed and broke.The patient was not affected or harmed during the incident.The item is being replaced.There was no significant delay to the case.The patient was fine.There was no harm to the patient.Device to be returned.

Manufacturer Narrative

(h3) the broken device reported was likely the result of the reamer contacting a tip of bone while reaming at full speed which led to fracture of the blades.

• Brand Name: EQUINOXE
• Type of Device: MDLR PRM RMR XLG PLT TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10967273
• MDR Text Key: 223442107
• Report Number: 1038671-2020-00641
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862085375
• UDI-Public: 10885862085375
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 315-25-15
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention