MAUDE Adverse Event Report: EXACTECH, INC.; POLY

Catalog Number 9999

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to breakage of the glenosphere screw.

Manufacturer Narrative

The revision reported was likely the result of the patient's fall, which caused the glenosphere locking screw to fracture."fracture of the prosthesis or any of its components may require a surgical intervention or revision" is listed in the device specific risks section of the equinoxe shoulder system ifu 700-096-060.

• Type of Device: POLY
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8394459
• MDR Text Key: 137949203
• Report Number: 1038671-2019-00126
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 9999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention