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

Model Number 314-13-33

Device Problem Inaccurate Information (4051)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

As reported, during an initial tsa on a (b)(6) y/o male patient, the team was completing a right anatomic shoulder with an eight-degree posterior augment.When the implant was opened, it was clearly a left that was packaged as a right.Luckily the surgeon noticed it before it was implanted.Another right posterior augment implant was opened, and it was the correct side in the package.There was no impact on the patient.The device was disposed of by the facility.

Manufacturer Narrative

Section h10: (h3) per capa2020-37, the part/label mismatch reported was likely the result of the not having requirements to check for implant¿s orientation during the entire process flow or part identification for the current design of the product family.

• Brand Name: EQUINOXE
• Type of Device: CAGE GLENOID M, POST AUG, RIGHT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10599771
• MDR Text Key: 208954398
• Report Number: 1038671-2020-00556
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862201010
• UDI-Public: 10885862201010
• Combination Product (y/n): N
• PMA/PMN Number: K113309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 314-13-33
• Device Catalogue Number: 314-13-33
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 100