MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; NARROW REV 42MM REAMER MODULAR, CANNULATED

Catalog Number	321-55-42
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during a procedure on a male patient, as the reamer was being taken off modular driver after reaming was finished the tip broke into 2 pieces.No parts or pieces fell into the wound site.There was no surgical delay.Patient was last known to be in stable condition following the event.Device to be returned.
Additional Manufacturer Narrative
Section h10: (h3) the broken device reported was likely the result of applying a counter clockwise resistance force to the instrument greater than yield strength of the material and subsequent sterilization cycles, which led to crack initiation, propagation, and ultimate failure.

• Brand Name: EQUINOXE
• Common Device Name: NARROW REV 42MM REAMER MODULAR, CANNULATED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10859768
• Report Number: 1038671-2020-00620
• Device Sequence Number: 2863855
• Product Code: KWT
• UDI-Device Identifier: 10885862232779
• UDI-Public: 10885862232779
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 321-55-42
• Device Lot Number: 123142028
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention