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

Model Number	320-20-34
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1038671-2022-00132
• Device Sequence Number: 5328549
• Product Code: KWT
• UDI-Device Identifier: 10885862086563
• UDI-Public: 10885862086563
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2024
• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male