MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; MDLR RVS RMR 42MM CNLTD

Catalog Number	321-35-42
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a procedure on this (b)(6) y/o male patient, while reaming the glenoid, the reamer jumped/jolted.We stopped reaming and realized the shaft that connects to the tri drive had a spiral fracture through it.Nothing fell into the patient.The reamer did not fully shatter, and we changed to a 46mm reamer.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Section h10: (h3) the broken device reported was likely the result of applying a counterclockwise resistance force to the instrument that was greater than the yield strength of the material which led to fracture of the post and the blades.

• Brand Name: EQUINOXE
• Common Device Name: MDLR RVS RMR 42MM CNLTD
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11914068
• Report Number: 1038671-2021-00258
• Device Sequence Number: 11647935
• Product Code: LXH
• UDI-Device Identifier: 10885862087812
• UDI-Public: 10885862087812
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/01/2021

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: 321-35-42
• Device Lot Number: 130311002
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 07/01/2021
• 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