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 Consequences Or Impact To Patient (2199)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during an initial tsa procedure, the surgeon was relocating the patient's shoulder at the end of the procedure when the skid snapped, causing a short delay.There were no effects to the patient caused by the delay.Surgeon had to remove part from the patient.Patient was last known to be in stable condition following the event.The device will be returned.
Additional Manufacturer Narrative
Section h10: (h3) based on previous similar complaint investigations 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 the fracture of the device.

• Brand Name: EQUINOXE
• Common Device Name: GLND SKID
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 11371602
• Report Number: 1038671-2021-00070
• Device Sequence Number: 2737391
• Product Code: LXH
• UDI-Device Identifier: 10885862084774
• UDI-Public: 10885862084774
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 315-03-01
• Device Lot Number: 73895002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown