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	Structural Problem (2506); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: serial #: (b)(6), catalog #: 320-10-05 - equinoxe reverse tray adapter plate tray +5 serial# unknown, catalog # 300-01-15 - equinoxe, humeral stem primary, press fit 15mmserial #: (b)(6), catalog #: 320-15-05 - eq rev locking screw, serial #: (b)(6), catalog #: 320-02-42 - rs expanded glenosphere 42mm, +4mm offset, serial #: (b)(6), catalog #: 320-20-00 - eq reverse torque defining screw kit.Multiple mdr reports were filed for this event, please see associated report: 1038671-2023-00030.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A review of manufacturing data was unable to be performed as the lot information of the product involved in the event was not available.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
As reported by an equinoxe shoulder clinical study, approximately 48 months post initial right side reverse total shoulder arthroplasty, the patient reported sitting and reaching out and then experienced sudden pain.Subsequently, 6 days after the onset of the pain, the patient underwent a right shoulder revision procedure.Post operatively it was noted to be humeral tray disassociation.Patient was revised with standard humeral stem, torque screw, humeral tray, humeral liner, glenosphere and glenosphere locking screw.The patient outcome was reported as resolved.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, d4, g3, g4, h4.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4, g3, h6, h11.Mdr section codes updated/corrected: a, b, g.The revision may have been the result of not replacing the humeral stem during the first revision due to humeral tray/torque screw disassociation, 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 and images/radiographs were not provided.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
• MDR Report Key: 22437449
• Report Number: 1038671-2025-02428
• Device Sequence Number: 3151494
• Product Code: KWT
• UDI-Device Identifier: 10885862086518
• UDI-Public: 10885862086518
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2025

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: 01/30/2024
• 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: 12/22/2022
• Supplement Date Received by Manufacturer: 07/14/2025; 10/10/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/14/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Race: White