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

Model Number	320-15-05
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, 8 days post op the initial right tsa, this (b)(6) female patient was revised because the original rtsa failed to seat the glenosphere correctly on the 8 degree posterior augment.Surgeon took screw out, seated glenosphere and used new locking screw.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Device will not be returning, disposed by hospital.
Additional Manufacturer Narrative
Section h10: (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 device was not returned for evaluation and pre-revision x-rays were not provided.

• Brand Name: EQUINOXE
• Common Device Name: 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: 14249250
• Report Number: 1038671-2022-00501
• Device Sequence Number: 20087315
• Product Code: KWT
• UDI-Device Identifier: 10885862086495
• UDI-Public: 10885862086495
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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 Expiration Date: 08/04/2026
• Device Model Number: 320-15-05
• Device Catalogue Number: 320-15-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female