MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM

Model Number 320-20-34

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 12/15/2021

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): 320-01-42 - equinoxe reverse 42mm glenosphere, (b)(4); 320-10-00 - equinoxe reverse tray adapter plate tray +0, (b)(4); 320-15-03 - rs glenoid plate l post aug, 8 deg, left, (b)(4); 320-15-05 - eq rev locking screw, (b)(4); 320-20-00 - eq reverse torque defining screw kit, (b)(4); 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(4); 320-42-00 - equinoxe reverse 42mm humeral liner +0, (b)(4).

Event Description

As reported, this (b)(6) y/o male patient's left shoulder was revised due to the baseplate screws breaking.The baseplate, glenosphere, tray, and liner were revised.Patient was last known to be in stable condition following the event.Devices will not be retuning due to hospital policy.

Manufacturer Narrative

Section h10: h3: the revision reported was likely the result of the glenoid baseplate not achieving long-term fixation, causing the compression screws to bear the joint load and eventually fracture.However, this cannot be confirmed as the devices were not returned for evaluation and adequate information was not provided to determine the root cause of the insufficient glenoid baseplate fixation.

• Brand Name: EQUINOXE
• Type of Device: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM
• 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: 13423459
• MDR Text Key: 284879992
• Report Number: 1038671-2022-00132
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086563
• UDI-Public: 10885862086563
• 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: 06/23/2022

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
• Device Model Number: 320-20-34
• Device Catalogue Number: 320-20-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 02/02/2022
• Supplement Dates Manufacturer Received: 06/02/2022
• Supplement Dates FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2019
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male