MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 42MMMM LNR TRL +0

Catalog Number 321-42-00

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/16/2022

Event Type  Injury  

Event Description

It was reported that during removal/withdrawal, the 42mm trial liner was removed from the male patient's right shoulder after trailing and some residual yellow particles were left in the patient.The yellow residual was only found on the adapter tray.The surgeon used a small forceps and fluid to remove the pieces.The surgical site was clean close up.There was no surgical delay.Patient was last known to be in stable condition following the event.Device is returning for evaluation.Revision stated in experience report was captured under 1038671-2022-00200 / case- (b)(4).

Manufacturer Narrative

Device evaluated by mfr: pending evaluation.

Manufacturer Narrative

Based on historical complaint investigations and the returned device, the damaged device reported was likely the result of numerous surgical uses in addition to coming in contacting with other surgical instrumentation during trialing and reprocessing.

• Brand Name: EQUINOXE
• Type of Device: 42MMMM LNR TRL +0
• 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: 13859184
• MDR Text Key: 287674039
• Report Number: 1038671-2022-00274
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862087911
• UDI-Public: 10885862087911
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: UNK
• 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: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 321-42-00
• Device Lot Number: 259379025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male