MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE HUMERAL ADAPTER TRAY

Model Number 320-10-00

Device Problem Insufficient Information (3190)

Patient Problem Rupture (2208)

Event Date 05/28/2014

Event Type  Injury  

Event Description

Revision of equinoxe shoulder components due to rupture of subscapularis tendon.Event was discovered 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 eval.Additionally, the device specific info was not provided, precluding a review of the device history record.

• Brand Name: EQUINOXE REVERSE HUMERAL ADAPTER TRAY
• Type of Device: HUMERAL ADAPTER TRAY
• Manufacturer (Section D): EXACTECH, INC.; 2320 n.w. 66th ct.; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 n.w. 66th ct.; gainesville, FL 32653
• MDR Report Key: 4008194
• MDR Text Key: 4777615
• Report Number: 1038671-2014-00331
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-10-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/02/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 118