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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, the surgeon was reaming the glenoid as preparation for the implant.When the surgeon was using his final reamer for the xl glenoid implant, the reamer caught part of a retractor, and broke.This was understood by the surgeon that the reamer was being pushed with significant force, and when it caught a solid piece of the metal the reamer the force being put on the reamer caused it to break.The patient was not injured due to this, and there was only a minimal delay to the surgery.The patient was not harmed in the processed.There were no parts or pieces that fell into the open wound.Patient was last known to be in stable condition following the event.The device will return for evaluation.

Manufacturer Narrative

Section h10: (h3) the broken reamer reported in (b)(4) was likely the result of the reamer coming in contact with a retractor during use which led to brittle 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: 11496839
• MDR Text Key: 240340841
• Report Number: 1038671-2021-00113
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 315-25-15
• Device Lot Number: 119750002
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention