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

Model Number	MDLR PRM RMR XLG PLT TIP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during a reverse total shoulder on a (b)(6) y/o male patient, the glenoid had an exterior lip to it and the surgeon needed a larger reamer just to correctly ream this lip down.When reaming, the reamer came apart (destroyed) from the middle.All pieces were removed from the patient and accounted for.No injury occurred to the patient.
Additional Manufacturer Narrative
Section h10: (h3) the broken reamer reported was likely the result of reaming off-axis under high loads while trying to corrective ream an exterior lip on the glenoid.Section h11: the following sections have corrected information: (d4) model number: na.

• 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: 9805014
• Report Number: 1038671-2020-00242
• Device Sequence Number: 643690
• Product Code: LXH
• UDI-Device Identifier: 10885862085375
• UDI-Public: 10885862085375
• 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): 04/23/2020

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 Model Number: MDLR PRM RMR XLG PLT TIP
• Device Catalogue Number: 315-25-15
• Device Lot Number: 46601005
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 04/23/2020
• 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
• Patient Age: 60 YR