MAUDE Adverse Event Report: EXACTECH, INC. EQ REV LOCKING SCREW; REVERSE SHOULDER COMPONENTS

Catalog Number 320-15-05

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 11/06/2021

Event Type  Injury  

Event Description

It was reported that this female patient received a revision for unknown reasons.No other patient information or medical history is available.

Manufacturer Narrative

Device evaluated by manufacturer? pending evaluation.

Manufacturer Narrative

(h3) the cause of the ¿injury¿ reported cannot be determined at this time due to the limited information provided.No specific allegations or failures were reported and it is unclear if the patient has been revised.

Manufacturer Narrative

H3: the revision reported was likely the result of not fully seating/engaging the glenosphere locking screw at the time of implantation, possibly due to misassembly of the glenosphere on the glenoid plate, which allowed for the screw to fracture and the components to disassemble.However, the exact cause and order of events cannot be confirmed because the revised components were not returned to exactech for evaluation and no images or radiographs were provided.

• Brand Name: EQ REV LOCKING SCREW
• Type of Device: REVERSE SHOULDER COMPONENTS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 13190437
• MDR Text Key: 283392168
• Report Number: 1038671-2022-00018
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-15-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2019
• 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 Sex: Female