MAUDE Adverse Event Report: EXACTECH, INC. EQ REVERSE TORQUE DEFINING SCREW KIT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-20-00
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patients right shoulder was revised approximately 1 year 5 months post op.Patient complained of pain.Tray disassembled from stem and screw broke.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
D10 concomitant devices: (b)(6) 320-42-00 - 145-deg pe 42mm hum liner +0 extremity shoulder.(b)(6) 320-10-15 - humeral tray +15mm.H3: 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.
Additional Manufacturer Narrative
The revision reported may have been due to fracture of the reverse torque screw and subsequent humeral tray disassembly.However, the reported fracture and sequence of events could not be confirmed.Additionally, potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation.H4: corrected.H6: corrected component, and investigation clinical codes.H10: corrected.

• Brand Name: EQ REVERSE TORQUE DEFINING SCREW KIT
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21145972
• Report Number: 1038671-2025-00222
• Device Sequence Number: 9097457
• Product Code: KWS
• UDI-Device Identifier: 10885862086518
• UDI-Public: 10885862086518
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K082702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 08/08/2025

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?: 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: 12/26/2024
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 08/08/2025
• Date Device Manufactured: 04/26/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male