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); Material Deformation (2976)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial right reverse total shoulder arthroplasty.Subsequently, it was reported that the patient's humeral tray disassociated from the humeral stem.As a result, the patient underwent a right shoulder revision approximately 1 year and 3 months after initial implantation.During the revision it was noted that the torque defining screw was bent and had separated from the humeral stem.The threads in the previous stem were reported to be undamaged, and the stem was retained for the revision.Cultures taken at the time of revision grew p.Acnes.No further patient impact reported.No further information available.
Additional Manufacturer Narrative
D10: 300-01-15 - equi, hum stem prim, press fit 15mm: (b)(6).320-15-05 - eq rev locking screw: (b)(6).322-42-00 - 145-deg pe 42mm hum liner +0: (b)(6).320-06-42 - glenosphere 42mm: (b)(6).320-15-08 - sup/post aug plate, r rs glen baseplate: (b)(6).320-20-34 - eq rev comp scr lck cap kit, 4.5 x 34mm: (b)(6).320-20-38 - eq rev comp scr lck cap kit, 4.5 x 38mm: (b)(6).531-55-88 - ergo gps 3.2mm drill kit sterile: (b)(6).531-78-20 - shouldr gps hex pins kit: (b)(6).A10012 - gps implant kit v2: (b)(6).320-10-10 - equ reverse tray adapter plate tray +10: (b)(6).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.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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 23477780
• Report Number: 1038671-2025-03271
• Device Sequence Number: 10558908
• Product Code: KWT
• UDI-Device Identifier: 10885862086518
• UDI-Public: 10885862086518
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2025

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 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: 10/17/2025
• Initial Report FDA Received Date: 11/05/2025
• Date Device Manufactured: 05/23/2024
• 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; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male