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

Catalog Number	315-25-15
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem 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.
Additional 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
• Common Device Name: MDLR PRM RMR XLG PLT TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11496839
• Report Number: 1038671-2021-00113
• Device Sequence Number: 2856612
• Product Code: KWT
• UDI-Device Identifier: 10885862085375
• UDI-Public: 10885862085375
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: 315-25-15
• Device Lot Number: 119750002
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/06/2021
• 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