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

Model Number 314-13-34

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

Pending evaluation.

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
• Type of Device: 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
• MDR Text Key: 293535649
• Report Number: 1038671-2022-00647
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862201027
• UDI-Public: 10885862201027
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113309
• 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: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2019
• 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: 69 YR
• Patient Sex: Male