MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; SUP/POST AUG PLATE, R RS GLENOID BASEPLATE

Model Number	SPECIFIC DEVICE NOT REPORTED
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, approximately 3 years post op the initial rsta, this (b)(6) y/o male patient was revised due to unknown reasons.Patient does now know when implant broke.The cage of the baseplate and a screw broke in the scapula.Broken implants were removed and revised to a reverse.Patient was last known to be in stable condition following the event.Devices will not be retuning.
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, approximately 3 years post op the initial rsta, this (b)(6) y/o male patient was revised due to unknown reasons.Patient does now know when implant broke.The cage of the baseplate and a screw broke in the scapula.Broken implants were removed and revised to a reverse.Patient was last known to be in stable condition following the event.Devices will not be retuning.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported may have been the result of an insufficient fixation of the baseplate on the glenoid, the lack of a/p compression screws to help resist rocking of the implant in those directions, and patient-related conditions, which ultimately led to the fracture of the baseplate cage and inferior compression screw.However, this cannot be confirmed as the devices were not returned for evaluation.Section h11: *the following sections have corrected information: (h6) component code: 4755, part/component/sub-assembly term not applicable.

• Brand Name: EQUINOXE
• Common Device Name: SUP/POST AUG PLATE, R RS GLENOID BASEPLATE
• 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: 13590310
• Report Number: 1038671-2022-00222
• Device Sequence Number: 3860788
• Product Code: KWT
• UDI-Device Identifier: 10885862242563
• UDI-Public: 10885862242563
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2022

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 Model Number: SPECIFIC DEVICE NOT REPORTED
• Device Catalogue Number: 320-15-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2018
• 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; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male