MAUDE Adverse Event Report: EXACTECH, INC. EQ REV LOCKING SCREW; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQ REV LOCKING SCREW
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: concomitant products.Equinoxe reverse 38mm glenosphere (cat# 320-01-38 / serial# (b)(4).Equinoxe reverse 38mm humeral liner +0 (cat# 320-38-00 / serial# (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported approximately one year post initial tsa, the female patient complained of pain.The doctor requested an mri and verified that the screw.Reverse glenosphere was broken.Verified by resonance that the prosthesis was correctly fixed.Explanted material will be sent for analysis.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely the result of either off-axis seating of the glenosphere on the baseplate or incomplete seating of the glenosphere locking screw at the time of implantation.Incomplete seating of the screw may have been due to bone graft or allograft being retained on the screw-hole threads of the baseplate, the glenosphere locking screw being cross-threaded into the baseplate, or a combination of the two, which led to the inability to fully seat the glenosphere onto the baseplate.However, this cannot be confirmed as the devices were not returned for evaluation, and photographs of the explanted devices and immediate post-operative radiographs of the index surgery were not provided.The most probable root cause associated with the reported event of ¿screw breakage¿ is associated with a partial or full-thickness crack of a screw, either during implantation or sometime after.Furthermore, the most probable root cause associated with the event of ¿device dislodged or dislocated¿ is associated with the device not remaining in an expected location.Section d10: device available for evaluation.

• Brand Name: EQ REV LOCKING SCREW
• 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: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16541948
• Report Number: 1038671-2023-00435
• Device Sequence Number: 12565704
• Product Code: KWT
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2026

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: 06/02/2026
• Device Model Number: EQ REV LOCKING SCREW
• Device Catalogue Number: 320-15-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 08/03/2023; 09/22/2026
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 08/28/2023; 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• 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 Sex: Female