MAUDE Adverse Event Report: EXACTECH, INC. EQ REVERSE TORQUE DEFINING SCREW KIT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-20-00

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 08/23/2023

Event Type  Injury  

Event Description

As reported, the patient had an initial right tsa on an (b)(6) 2021.The patient was dislocating and came in to see the surgeon.The patient was revised on (b)(6) 2023 and the screw was found to be stripped.There was no reported surgical delay/prolongation.The patient outcome is unknown.

Manufacturer Narrative

H3: pending investigation.D10: 320-10-05 - equinoxe reverse tray adapter plate tray +5 6993379 320-42-00 - 145-deg pe 42mm hum liner +0 s313393.

• Brand Name: EQ REVERSE TORQUE DEFINING SCREW KIT
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18008394
• MDR Text Key: 326555103
• Report Number: 1038671-2023-02607
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086518
• UDI-Public: 10885862086518
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-20-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2021
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female