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

Catalog Number	315-25-11
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during a procedure, the reamer broke while reaming the glenoid on drill.The surgical site was checked and confirmed clean by (b)(6) and surgical staff.When replaced the reamer and continued the procedure with no surgical delay.The patient is in stable condition.Device to be returned.
Additional Manufacturer Narrative
Section h10: h3: based on historical complaint investigations and the returned device, the broken reamer reported was likely the result of the reamer experiencing high loads possibly during off-axis reaming and/or coming in contact with hard bone, which led to brittle fracture.Section h11: the following sections have corrected information: f10: adverse event problem: please disregard information, it should be blank.

• Brand Name: EQUINOXE
• Common Device Name: MDLR PRM RMR XSM PLT TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12258548
• Report Number: 1038671-2021-00367
• Device Sequence Number: 3589872
• Product Code: LXH
• UDI-Device Identifier: 10885862085337
• UDI-Public: 10885862085337
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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: 315-25-11
• Device Lot Number: 105364016
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 08/12/2021
• 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