MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; CAGE GLENOID L, POST AUG, RIGHT

Model Number	314-13-34
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon used a caged augmented glenoid in his case.They followed the surgical steps and then tried to implant the glenoid.The (b)(6) patient's bone was very hard and they were unable to seat the implant.The surgeon then tried to remove the implant but two of the metal pieces disengaged and stayed in the glenoid.It was very difficult to remove the two parts.They then implanted a all poly one to complete the case.There was a 5-15 mins surgical delay/prolongation, no adverse events as a result of the delay prolongation.The patient had no adverse affects.
Additional Manufacturer Narrative
Pending evaluation.
Additional Manufacturer Narrative
Section h10: (h3) the seating difficulty reported was likely the result of incomplete or off-axis drilling of one or more of the prepared holes, which prevented the glenoid pegs/center cage from fully seating and allowed for disengagement of the center cage and one of the peripheral pegs.The patient¿s reported ¿very hard¿ glenoid bone likely contributed to this event.Section h11: *the following sections have corrected information: (h6) component code: 4720, anchor.

• Brand Name: EQUINOXE
• Common Device Name: CAGE GLENOID L, POST AUG, RIGHT
• 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: 14631649
• Report Number: 1038671-2022-00647
• Device Sequence Number: 5918759
• Product Code: KWT
• UDI-Device Identifier: 10885862201027
• UDI-Public: 10885862201027
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: 07/23/2024
• Device Model Number: 314-13-34
• Device Catalogue Number: 314-13-34
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2019
• 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: 69 YR
• Patient Sex: Male