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

Catalog Number 315-03-01

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2021

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 233245532
• Report Number: 1038671-2021-00070
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10885862084774
• UDI-Public: 10885862084774
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention