MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL TRAY SCREW

Device Problems Disconnection (1171); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Injury (2348)

Event Date 07/11/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to the humeral tray screw disengaging after the patient fell and the tray came loose.

Manufacturer Narrative

Section h10: (b2) outcomes attributed to adverse event: added check for hospitalization - initial or prolonged (h3) as reported, a revision was completed after the patient fell and the humeral tray screw became disengaged causing the tray to come loose.No other information was made available.There is no indication that there is a device related problem, the injury was caused by a patient fall.The most likely cause of the reported event appears to be an adverse event caused by the patient fall.(h6) evaluation codes: 2348, 2993.Section h11: the following sections have corrected information: (b5) describe event or problem: as reported, a revision was completed after the patient fell and the humeral tray screw became disengaged causing the tray to come loose.No other information was made available.

Event Description

As reported, a revision was completed after the patient fell and the humeral tray screw became disengaged causing the tray to come loose.No other information was made available.

• Brand Name: EQUINOXE
• Type of Device: HUMERAL TRAY SCREW
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8837875
• MDR Text Key: 152536499
• Report Number: 1038671-2019-00379
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 07/29/2019
• Supplement Dates Manufacturer Received: 05/08/2020
• Supplement Dates FDA Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention