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

Model Number EQ REVERSE TORQUE DEFINING SCREW KIT

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 02/22/2023

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product(s): 11 stem (cat# 320-01-11); 145-deg pe 38mm hum liner +0 (cat# 320-38-00 / serial# (b)(4)); equinoxe reverse tray adapter plate tray +5 (cat# 320-10-05 / serial# (b)(4)) additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, patient had to revise a shoulder for the second time due to the humeral tray breaking apart from the stem.Patient was revised to exactech devices.There were no fragments that felt into the patient wound site.There was no surgical delay/prolongation.Patient is ok after revision.No images received.The devices are not available for evaluation due to hospital kept the devices.

Manufacturer Narrative

After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3 the revision reported may have been the result of not replacing the humeral stem during the first revision, which may have led to implanting a new torque defining screw into a humeral stem with damaged threads.This deformation likely did not allow for the new torque screw to be fully seated during the first revision surgery, resulting in the torque defining screw backing out of the humeral stem and subsequently the humeral tray disassociating from the humeral stem.However, this cannot be confirmed as the devices were not returned for evaluation, images/radiographs were not provided, and information regarding the index surgery and first revision surgery were unable to be obtained.

• 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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16529834
• MDR Text Key: 311151364
• Report Number: 1038671-2023-00420
• 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,Followup
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EQ REVERSE TORQUE DEFINING SCREW KIT
• Device Catalogue Number: 320-20-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2022
• 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): Required Intervention
• Patient Sex: Male