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)
Date of Event	10/10/2024
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: 320-10-10 equi rev tray adapter plate tray +10: (b)(6).300-30-08 - equinoxe preserve stem 8mm: (b)(6).320-06-38 - glenosphere 38mm: (b)(6).320-15-05 - eq rev locking screw: (b)(6).320-15-07 - sup/post aug plate, l rs glenoid baseplate: (b)(6).320-20-26 - eq rev comp screw lck cap kit, 4.5 x 26mm: (b)(6).320-20-26 - eq rev comp screw lck cap kit, 4.5 x 26mm: (b)(6).320-20-34 - eq rev comp screw lck cap kit, 4.5 x 34mm: (b)(6).320-20-34 - eq rev comp screw lck cap kit, 4.5 x 34mm: (b)(6).320-38-03 - 145-deg pe 38mm hum liner +2.5: (b)(6).
Event or Problem Description
As reported, approximately 10 months and 6 days post the initial left reverse total shoulder arthroplasty, the patient came in to the clinic and described a pop sensation when reaching behind their back.X-ray showed a dissociated tray.The torque screw managed to back out and the tray dissociated from the stem.A revision was performed and the stem was extracted and a new one implanted.A +10 tray was used, and a 38mm poly.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 updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, g.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 patient conditions, incomplete seating or forces on the underside of the humeral tray at the time of implantation secondary to unintended contact with protruding bone, or an issue with insufficient application of torque or cross-threading of the screw during assembly.However, this cannot be confirmed because the components were not returned for evaluation.Should additional relevant information be obtained, a follow-up mdr will be submitted 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: 21994377
• Report Number: 1038671-2025-02015
• Device Sequence Number: 4263582
• Product Code: KWT
• UDI-Device Identifier: 10885862086518
• UDI-Public: 10885862086518
• Combination Product (Y/N): N
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2025

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?: No
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 10/08/2025
• Date Device Manufactured: 10/18/2023
• 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: 68 YR
• Patient Sex: Male