BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE CUTTER-STANDARD

    MDR report key: 3898554 · Received June 26, 2014

    Report

    Report Number
    2520274-2014-12209
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HXZ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE USED IN A VETERINARY CASE. NO PATIENT INFORMATION WILL BE REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE LOT NUMBER PROVIDED COULD NOT BE VERIFIED THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING VETERINARY SURGERY FOR A FRACTURE REPAIR ON A RADIUS BONE ON A CANINE WHILE CUTTING THE WIRE THE SURGEON NOTICED THAT BOTH CUTTING INSTRUMENTS WERE CHIPPED. THE SURGEON USED ANOTHER INSTRUMENT THAT WAS AVAILABLE TO COMPLETE THE SURGERY. THIS RESULTED IN AN ADDITIONAL 5 MINUTES ADDED TO SURGERY TIME. IT WAS REPORTED THAT NO FRAGMENTS WERE OBSERVED DURING SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE WAS NO HUMAN PATIENT INVOLVEMENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373584 CABLE CUTTER-STANDARD CUTTER,WIRE HXZ SYNTHES (USA) 71170065

    Patients

    Seq Age Sex Outcome Treatment
    1