MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE SHOULDER COMPONENTS

Device Problem Physical Property Issue (3008)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 08/10/2017

Event Type  Injury  

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the device was not returned.Additionally, the device specific information was not provided, precluding a review of the device history record.Pending evaluation.

Event Description

Revision of shoulder components due to stripped threads in screw.

Manufacturer Narrative

This emdr should be voided as it is a duplicate of another file and was submitted in error.Correct emdrs are: 1038671-2017-00623, 1038671-2017-00624, and 1038671-2017-00625.

Event Description

Revision of shoulder components due to stripped threads in screw.

• Brand Name: EQUINOXE SHOULDER COMPONENTS
• Type of Device: SHOULDER COMPONENTS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 6812761
• MDR Text Key: 83366011
• Report Number: 1038671-2017-00622
• 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,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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