BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD MEDIUM CURVED

    MDR report key: 3094003 · Received May 6, 2013

    Report

    Report Number
    0001811755-2013-01031
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 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

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED. FAILURE ANALYSIS IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DISASSEMBLY AT THE MANUFACTURER FACILITY, A PIECE OF BROKEN BUR WAS FOUND IN 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 DISASSEMBLY AT THE MANUFACTURER FACILITY, A PIECE OF BROKEN BUR WAS FOUND IN 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
    196266 SD/PD MEDIUM CURVED DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 12067

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BUR