MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REV LOCKING SCREW

Model Number 320-15-05

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 11/11/2021

Event Type  Injury  

Event Description

As reported, the rep was notified by the surgeon¿s p.A.Of an x-ray of a 80 y/o female patient that was initially done approximately 1 yr ago.On x-ray on l shoulder, it appeared that the glenosphere screw had come out and the glenosphere was dislodged.The p.A stated would probably revise on (b)(6) 2021.On the day of surgery, it was noted the screw was actually broken and did not simply come out.Screw pieces were removed.The glenoid plate was tested with a new screw with no problems.New glenosphere and new screw was implanted and appeared to be down on x-ray.Patient was last known to be in stable condition following the event.Devices will not return due to facility policy.

Manufacturer Narrative

Pending evaluation.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of cross-threading of the locking screw and the glenosphere not being fully seated at the time of the initial surgery, which likely did not allow for complete seating of the glenosphere locking screw.The system is intended to transmit forces through the glenosphere to the glenoid baseplate.When not fully seated, it is possible for the forces to be transmitted thought the glenosphere and the screw, creating forces on the screw that cannot be supported.

• Brand Name: EQUINOXE
• Type of Device: REV LOCKING SCREW
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 12933388
• MDR Text Key: 281744320
• Report Number: 1038671-2021-00661
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086495
• UDI-Public: 10885862086495
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-15-05
• Device Catalogue Number: 320-15-05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female