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

Catalog Number	321-42-00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/16/2022
Type of Reportable Event	Serious Injury
Event or Problem 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).
Additional Manufacturer Narrative
Device evaluated by mfr: pending evaluation.
Additional 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
• Common Device Name: 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
• Report Number: 1038671-2022-00274
• Device Sequence Number: 870767
• Product Code: KWT
• UDI-Device Identifier: 10885862087911
• UDI-Public: 10885862087911
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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 Catalogue Number: 321-42-00
• Device Lot Number: 259379025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Male