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 Codes	Detachment of Device or Device Component (2907); Misassembly by Users (3133)
Health Effect - Clinical Code	Fall (1848)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.D10: (b)(6), 320-42-13 - equinoxe reverse 42mm humeral const liner +2.5, (b)(6), 320-10-10 - equinoxe reverse tray adapter plate tray +10, (b)(6), 300-01-17 - equinoxe humeral stem primary press fit 17mm, (b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, (b)(6), 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm, (b)(6), 320-15-05 - eq rev locking screw, (b)(6), 315-35-00 - glnd kwire, (b)(6), 320-15-01 - eq rev glenoid plate, (b)(6), 320-01-42 - equinoxe reverse 42mm glenosphere, (b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(6), 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.
Event or Problem Description
As reported, approximately 4 years and 5 months post the initial right reverse total shoulder arthroplasty, the patient experienced a fall, resulting in the disassociation of the humeral tray and liner from the humeral stem component.Upon viewing relevant x-rays and ct scans, it appeared the torque defining screw was intact and undamaged from the fall, suggesting the screw had been improperly tightened during the primary surgery, and resultingly backed out over time.Subsequently, when the patient experienced the fall, the morse taper holding the humeral tray and stem together disengaged, causing the dissociation.This was correlated by the surgeon.Like for like replacements were implanted for adapter tray, torque defining screw, liner and glenosphere.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: h6.The reason for the revision is likely due to the disassembly of the torque defining screw and thus the humeral tray and liner assembly from the humeral stem.Potential contributions may include the reported traumatic event or misassembly of the torque screw during initial implantation.However, this cannot be confirmed as devices were not returned and the view of the torque screw in the provided images does not provide sufficient visibility of the threads to assess damage.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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21551684
• Report Number: 1038671-2025-01488
• Device Sequence Number: 8164637
• Product Code: KWT
• UDI-Device Identifier: 10885862086518
• UDI-Public: 10885862086518
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2025
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2020
• 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: Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male