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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 77 yo male patient, initial right shoulder implanted in (b)(6) 2022, underwent a revision procedure on an unknown date.The torque screw backed out of the stem completely.The tray dissociated from the stem.A new tray with torque screw was placed by the surgeon, as well as a new poly and glenosphere.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.X-rays were provided.The device is available for return.No device images were provided.No further information.
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.(b)(6) 320-08-38 - glenosphere exp 38mm +4mm offset.(b)(6) 320-10-05 - equinoxe reverse tray adapter plate tray +5.(b)(6) 320-15-04 - rs glenoid plate r post aug, 8 deg, right.(b)(6) 320-15-05 - eq rev locking screw.(b)(6) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6) 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.(b)(6) 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.(b)(6) 320-38-00 - 145-deg pe 38mm hum liner +0.(b)(6) 531-20-00 - shldr gps rvrs drill kit.(b)(6) 531-78-20 - shouldr gps hex pins kit.03073222270 (b)(6) - gps implant kit v2.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, h6 mdr section codes updated/corrected: b, c, d, g the revision reported was likely the result of torque screw disassembly leading to humeral tray disassociation.The cause of the disassembly cannot be confirmed from the information provided, but may be related to incomplete seating during implantation, fracture, or abnormal forces resulting in the screw backing out over time.However, the series of events cannot be confirmed and potential contributions of user or patient-related considerations to the event cannot be confirmed as the devices were not returned for evaluation and product images and initial post-operative 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19955930
• Report Number: 1038671-2024-02765
• Device Sequence Number: 15653815
• Product Code: KWT
• UDI-Device Identifier: 10885862086518
• UDI-Public: 10885862086518
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/02/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• 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: 77 YR
• Patient Sex: Male