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

Catalog Number	320-20-00
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 6741280 300-01-12 - equinoxe humeral stem primary press fit 12mm.6832516 320-06-38 - glenosphere 38mm.6707858 320-10-05 - equinoxe reverse tray adapter plate tray +5.6662251 320-15-01 - eq rev glenoid plate.6827764 320-15-05 - eq rev locking screw.S214496 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.S102837 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.S235040 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.6441593 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.6784793 321-20-00 - equinoxe reverse shoulder drill kit.
Event or Problem Description
It was reported that this 88y/o male patient was revised approximately 3 years 6 months post op.Torque screw broke and poly wore.Joint looked overstuffed, baseplate put in too high.Surgeon heavily debrided and used rongeur to remove.Surgeon removed and converted to competitors reverse.Patient was last known to be in stable condition following the event.Product not returning: implants were left at the hospital.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: g3, h6, h11.Mdr section codes updated/corrected: b, c, d, g.The revision reported was likely the result of torque screw fracture.The cause of the fracture cannot be conclusively determined but may be due to a superiorly placed glenoid baseplate resulting in abnormal forces from impingement of the humeral tray and native glenoid bone.The wear noted on the polyethylene humeral liner is likely the result of a combination of impingement with the scapula secondary to a malpositioned glenoid baseplate and motion of the humeral tray following the torque screw fracture.However, the series of events cannot be confirmed and potential contributions of user related considerations could not be assessed as the devices were not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQ REVERSE TORQUE DEFINING SCREW KIT
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20239939
• Report Number: 1038671-2024-03566
• Device Sequence Number: 12752885
• Product Code: KWT
• UDI-Device Identifier: 10885862086518
• UDI-Public: 10885862086518
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/13/2025
• Device Catalogue Number: 320-20-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male