MAUDE Adverse Event Report: EXACTECH, INC EQUINOXE SCREW

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 07/18/2016

Event Type  malfunction  

Manufacturer Narrative

Pending engineering evaluation.

Event Description

Revision due to loosening.

Manufacturer Narrative

Engineering evaluation noted that the revision was likely the result of not fully engaging the screw during initial implantation, leading to the fatigue failure of the screw and glenosphere disassociation.

Event Description

Revision due to loosening.

• Brand Name: EQUINOXE SCREW
• Type of Device: SCREW
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 5885328
• MDR Text Key: 53443093
• Report Number: 1038671-2016-00504
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2016,09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Is the Reporter a Health Professional?: No
• Date Report to Manufacturer: 07/21/2016
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention