BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD LONG CURVED

    MDR report key: 3032139 · Received April 3, 2013

    Report

    Report Number
    0001811755-2013-00682
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 9, 2013
    Report Date
    March 9, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORTING OF THE EVENT REPORTED ON ASR ID (B)(4).

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. SEVERAL FACTORS COULD CAUSE FAILURES FOR BUR BREAKS INCLUDING, USER APPLIED SIDE LOADING, BUR EXPOSURE, RUNNING SPEED AS WELL AS ATTACHMENT AND DRILL CONDITIONS. THE DEVICE WAS NOT RETURNED TO THE USER FACILITY, AS IT WAS SCRAPPED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY, A BROKEN BUR WAS FOUND WITHIN THE ATTACHMENT. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY, A BROKEN BUR WAS FOUND WITHIN THE ATTACHMENT. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136710 SD/PD LONG CURVED DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 12016

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BUR