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 Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 10/03/2023

Event Type  Injury  

Manufacturer Narrative

Section h10: (h3) pending evaluation.(d10) concomitant device(s): 4467224 320-42-00 - equinoxe reverse 42mm humeral liner +0.3522977 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.4105861 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.4266101 320-10-05 - equinoxe reverse tray adapter plate tray +5.4399805 320-15-01 - eq rev glenoid plate.4432889 320-01-42 - equinoxe reverse 42mm glenosphere.4468308 320-15-05 - eq rev locking screw.4507117 300-01-11 - equinoxe, humeral stem primary, press fit 11mm.4518583 321-20-00 - equinoxe reverse shoulder drill kit.4519509 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.4519510 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.

Event Description

As reported, approximately 7 years post op initial tsa, this 57 y/o male patient was revised due to a stripped torque screw.Patient was last known to be in stable condition following the event.No images or x-rays available.Device is returning.

• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 ct; gainesville, FL 32653
• MDR Report Key: 18011318
• MDR Text Key: 326614897
• Report Number: 1038671-2023-02611
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2021
• Device Catalogue Number: 320-20-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Age: 57 YR
• Patient Sex: Male