MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLND SKID

Catalog Number	315-03-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, the surgeon was trialing implant sizes, used skid to dislocate shoulder and it snapped.The male patient was last known to be in stable condition following the event.No parts or pieces fell into the patient.The device is to be returned.
Additional Manufacturer Narrative
Section h10: (h3) based on previous complaint investigation history, the description of the incident, and the returned device, the broken glenoid skid reported was likely the result of applying a bending moment to one end of the instrument which led to fracture of the device.

• Brand Name: EQUINOXE
• Common Device Name: GLND SKID
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12331139
• Report Number: 1038671-2021-00391
• Device Sequence Number: 16850392
• Product Code: LXH
• UDI-Device Identifier: 10885862084774
• UDI-Public: 10885862084774
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/20/2021

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: 315-03-01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention