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

Catalog Number	320-15-05
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Joint Laxity (4526); Insufficient Information (4580)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 01300166 320-35-08 equinoxe small reverse shoulder small reverse baseplate - superior posterior right.09260679 320-10-00 humeral adapter tray, +0.322-40-00 145-deg pe 40mm const hum liner +0.320-20-00 eq reverse torque defining screw kit.320-20-42 eq rev compress screw lck cap kit, 4.5 x 42mm.320-20-26 eq rev compress screw lck cap kit, 4.5 x 26mm.320-20-30 eq rev compress screw lck cap kit, 4.5 x 30mm.320-20-18 eq rev compress screw lck cap kit, 4.5 x 18mm.Primary stem.
Event or Problem Description
It was reported that this patient's right shoulder was revised.The patient described feeling rocking in the shoulder with range of motion.Surgeon reached out to request instruments for extraction and revision of current implant.Axial view demonstrated a misaligned glenoshpere which appeared to be sitting off the baseplate.No glenosphere locking screw was visualized on x-ray.Coronal view appeared normal.Upon exposure of the joint, the glenosphere was loose and the locking screw appeared to be broken.Surgeon inspected baseplate and noticed screw was broken into the center hole, which it inserts into.Surgeon proceeded to extract locking caps and screws using the hex driver and successfully extracted without screws breaking.Once screws where taken out of the patient, another surgeon assisting on the case, extracted the baseplate via hospital instruments.Doctors took the liner off via mallet and elevator, then removed torque screw with removal tool to take the tray off.Stem was well fixed.Patient was last known to be in stable condition following the event.Product not returning: please ask hospital for return of products.
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, e, g serial number, expiration and manufactured dates unknown.The revision reported was likely the result of prosthesis fracture of the equinoxe reverse locking screw leading to improper seating of the glenosphere.A contributing factor to the event could have been initial improper seating of the glenosphere, leading to abnormal forces applied to the screw and subsequent fracture.A secondary finding would be prosthesis wear of the humeral liner, likely due to abnormal articulation with an unknown metal component following the fracture.However, the cause of the fracture and prosthesis wear cannot be confirmed and potential contributions of manufacturing, user, or patient-related considerations could not be assessed as the devices were not returned for evaluation 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 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20611734
• Report Number: 1038671-2024-04240
• Device Sequence Number: 8144341
• Product Code: KWT
• UDI-Device Identifier: 10885862086495
• UDI-Public: 10885862086495
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/15/2025

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: 320-15-05
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 68 YR
• Patient Sex: Male