MAUDE Adverse Event Report: EXACTECH, INC EQUINOXE REVERSE SHOULDER COMPRESSION SCREW/LOCKING CAP KIT

Catalog Number 320-20-30

Device Problems Failure To Adhere Or Bond (1031); Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2016

Event Type  malfunction  

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of glenoid loosening related to a combination of the patient's age, bone quality, and implant placement.

Event Description

Index surgery: (b)(6) 2010.Revision of left shoulder components due to a loose glenosphere with a broken screw.Infection likely.Surgeon states event is unlikely related to devices.This event report was received through clinical data collection activities.

• Brand Name: EQUINOXE REVERSE SHOULDER COMPRESSION SCREW/LOCKING CAP KIT
• Type of Device: COMPRESSION SCREW/LOCKING CAP KIT
• 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: 5628425
• MDR Text Key: 44587675
• Report Number: 1038671-2016-00314
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 320-20-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2016
• 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
• Patient Age: 88 YR
• Patient Weight: 65