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

Catalog Number	315-25-14
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during a shoulder procedure, after reaming the glenoid the large pilot tipped reamer was broken.The instrument was broken during removal.The site was checked for pieces, the surgeon confirmed, and patient was last known to be in stable condition.The device is being returned for evaluation.
Additional Manufacturer Narrative
Section h10: (h3) based on previous similar investigations, the fractured reamer blades reported were likely the result of the reamer experiencing high loads possibly during off-axis reaming and/or contact with hard bone or a retractor which led to brittle fracture of the blades.

• Brand Name: EQUINOXE
• Common Device Name: MDLR PRM RMR LG PLT TIP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11920816
• Report Number: 1038671-2021-00273
• Device Sequence Number: 16947609
• Product Code: LXH
• UDI-Device Identifier: 10885862085368
• UDI-Public: 10885862085368
• 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): 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: 315-25-14
• Device Lot Number: 3344005
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/02/2021
• 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