MAUDE Adverse Event Report: EXACTECH, INC EQUINOXE REVERSE HUMERAL LINER

Catalog Number 320-38-03

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Increased Sensitivity (2065)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient reports acromial tenderness.The case report form indicates the event is possibly related to devices and definitely related to procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

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

Event Description

Index surgery: (b)(6) 2016.Patient reports acromial tenderness on (b)(6) 2016.Post-op scapular fracture reported on (b)(6) 2016.This event report was received through clinical data collection activities.

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, device specific information was not provided, precluding a review of the device history record.Engineering evaluation noted that the acromial tenderness reported was likely the result of the scapular fracture that was not detected until a later appointment.

Event Description

Index surgery: (b)(6) 2016.Patient reports acromial tenderness on (b)(6) 2016.Post-op scapular fracture reported on (b)(6) 2016.This event report was received through clinical data collection activities.

• Brand Name: EQUINOXE REVERSE HUMERAL LINER
• Type of Device: HUMERAL LINER
• 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: 6145940
• MDR Text Key: 61490042
• Report Number: 1038671-2016-00828
• 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,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 320-38-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2016
• 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
• Patient Age: 68 YR
• Patient Weight: 64