BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SD/PD MEDIUM CURVED

    MDR report key: 3093534 · Received May 6, 2013

    Report

    Report Number
    0001811755-2013-01026
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT WITHOUT AN EVALUATION OF THE DEVICE. THE DEVICE WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED, IF ADDITIONAL INFORMATION IS OBTAINED AND REQUIRES REPORTING. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE LAMINECTOMY AT THE USER FACILITY, THE BUR HEAD BROKE OFF IN THE ATTACHMENT. THE USER FACILITY REPORTED THAT THE HEAD OF THE BUR WAS DISPOSED OF AND THAT THE BUR WAS STUCK IN THE ATTACHMENT. NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. UPON FOLLOW-UP, THE USER FACILITY REPORTED THE ADDITIONAL INFORMATION THAT THE BUR HEAD HAD BEEN REMOVED BY SUCTION AND DISPOSED OF. IT WAS REPORTED THAT NO ONE WAS HARMED OR INJURED BY THE BROKEN BUR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE LAMINECTOMY AT THE USER FACILITY, THE BUR HEAD BROKE OFF IN THE ATTACHMENT. THE USER FACILITY REPORTED THAT THE HEAD OF THE BUR WAS DISPOSED OF AND THAT THE BUR WAS STUCK IN THE ATTACHMENT. NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE LAMINECTOMY AT THE USER FACILITY, THE BUR HEAD BROKE OFF IN THE ATTACHMENT. THE USER FACILITY REPORTED THAT THE HEAD OF THE BUR WAS DISPOSED OF AND THAT THE BUR WAS STUCK IN THE ATTACHMENT. NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED. UPON FOLLOW-UP, THE USER FACILITY REPORTED THE ADDITIONAL INFORMATION THAT THE BUR HEAD HAD BEEN REMOVED BY SUCTION AND DISPOSED OF. IT WAS REPORTED THAT NO ONE WAS HARMED OR INJURED BY THE BROKEN BUR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196833 SD/PD MEDIUM CURVED DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 11266

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) MIS BUR, LOT UNKNOWN