BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO DRILL MEDIUM STRAIGHT ATTACHMENT

    MDR report key: 4063076 · Received September 5, 2014

    Report

    Report Number
    0001811755-2014-03151
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    EIA
    PMA / PMN Number
    K032117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER REASSESSMENT IT WAS DETERMINED THAT THIS EVENT WAS FILED IN ERROR. THE MICRO DRILL MEDIUM STRAIGHT ATTACHMENT DID NOT SEPARATE INTO PIECES. THE DEVICE WAS FOUND TO HAVE A LARGER THAN USUAL GAP BETWEEN THE NOSE AND NOSE HOUSING. THIS MALFUNCTION IS NOT KNOWN TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO RECUR.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    DURING FUNCTIONAL TESTING BY A SERVICE TECHNICIAN, IT WAS FOUND THAT THE DEVICE HAD A GAP BETWEEN THE NOSE HOUSING AND SHAFT OF THE ATTACHMENT. THE DEVICE WAS IN ONE PIECE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY, THE NOSE OF THE MICRO DRILL MEDIUM STRAIGHT ATTACHMENT WAS FOUND TO BE SEPARATING FROM THE NOSE HOUSING. IT WAS REPORTED THAT THERE WAS NO ASSOCIATED PROCEDURE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AFTER REASSESSMENT IT WAS DETERMINED THAT THIS EVENT WAS FILED IN ERROR. THE MICRO DRILL MEDIUM STRAIGHT ATTACHMENT DID NOT SEPARATE INTO PIECES. THE DEVICE WAS FOUND TO HAVE A LARGER THAN USUAL GAP BETWEEN THE NOSE AND NOSE HOUSING. THIS MALFUNCTION IS NOT KNOWN TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY THE NOSE OF THE MICRO DRILL MEDIUM STRAIGHT ATTACHMENT WAS FOUND TO BE SEPARATING FROM THE NOSE HOUSING. IT WAS REPORTED THAT THERE WAS NO ASSOCIATED PROCEDURE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545103 MICRO DRILL MEDIUM STRAIGHT ATTACHMENT UNIT, OPERATIVE DENTAL EIA STRYKER INSTRUMENTS-KALAMAZOO 12285

    Patients

    Seq Age Sex Outcome Treatment
    1