BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 2091768 · Received May 17, 2011

    Report

    Report Number
    1625507-2011-00068
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    K020069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT CONFIRMED. THE RETURNED ATTACHMENT WAS INSPECTED FOR DAMAGE. THE FOOT ON THE ATTACHMENT WAS DAMAGED. APPROXIMATELY 50% OF THE FOOT WAS MISSING. THIS WEAR OCCURS WHEN THE TIP OF THE TOOL CONTACTS THE FOOT ON A FOOTED ATTACHMENT DURING USE. THIS CONDITION CAN OCCUR WHEN THE TOOL IS NOT CORRECTLY SEATED IN A MOTOR COLLET. THE TOOL WAS INSPECTED UNDER MAGNIFICATION. THE DISTAL TIP OF THE TOOL WAS WORN. THIS WEAR OCCURS WHEN THE TIP OF THE TOOL CONTACTS THE FOOT ON A FOOTED ATTACHMENT DURING USE. ON FOLLOW-UP IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT. THE USER MANUAL CONTAINS THE FOLLOWING WARNING "THE ATTACHMENT SHOULD NOT BE USED IF ANY PART OF THE ATTACHMENT APPEARS TO BE BENT, LOOSE, MISSING, OR DAMAGED. EXCESSIVE PRESSURE OR IMPROPER HANDLING, SUCH AS BENDING OR PRYING, OF THE ATTACHMENT OR DISSECTING TOOL MAY CAUSE INJURY TO THE PATIENT, OPERATOR AND/OR OPERATING ROOM STAFF."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING THE CRANIAL OPENING OPERATION (ABOUT 3/4 OF THE OPERATION), THERE WAS A WEIRD SOUND HEARD FROM THE PENUMATIC DRILL MOTOR. THEN, THE SURGEON UNLOCKED THIS AF02 ATTACHMENT AND FOUND THE TIP WAS BROKEN OFF." NO PATIENT IMPACT WAS REPORTED. ON FOLLOW-UP, IT WAS CONFIRMED THAT THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TBD MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR F2/8TA23 LOT# 0004921139