BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEX DRIVER, 4.0 CANN/RET

    MDR report key: 2447814 · Received February 13, 2012

    Report

    Report Number
    1221934-2012-00034
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 3, 2012
    Manufacturer
    ORTHOTECH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING IS BEING RETURNED FOR EVALUATION; COMPLAINT DEVICE DISCARDED AT USER FACILITY. NO LOT NUMBER HAS BEEN SUPPLIED, WHICH PRECLUDES CONDUCTING A BATCH RECORD REVIEW TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. WE CANNOT TELL ANYTHING FROM THIS; CANNOT DISCERN THE UNDERLYING OR ROOT CAUSE FOR THE REPORTED DEVICE'S FAILURE MODE. AT THIS POINT IN TIME, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE AND GERMANE TO THIS ISSUE. ALSO, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC KNEE REPAIR, A PORTION OF THE DISTAL TIP OF A HEX DRIVER BROKE OFF INTO THE FIXATION SCREW WHILST THE SURGEON WAS DRIVING THE SCREW INTO THE BONE. THE TIP FRAGMENT WAS EASILY RETRIEVED FROM THE BODY AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. COMPLAINT DEVICE DISCARDED AT USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEX DRIVER, 4.0 CANN/RET ARTHROSCOPIC INSTRUMENTS HXX ORTHOTECH NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1