BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPS ELITE LONG ATTACHMENT

    MDR report key: 808757 · Received January 19, 2007

    Report

    Report Number
    MW1041663
    Event Type
    Injury
    Date Received
    January 19, 2007
    Report Date
    January 19, 2007
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    HBF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PT UNDERWENT NEUROSURGERY. THE SURGEON DOCUMENTED THAT THERE WAS A DEFECT IN THE DURA THAT WAS DRILL RELATED WHILE PERFORMING A LUMBAR LAMINECTOMY L4-L5, IN HIS OPERATIVE REPORT. LATE OCT 06/EARLY NOV 06 STAFF NOTED THAT THE 6MM ROUND BURR WAS BECOMING UNSEATED FROM DRILL ATTACHMENT. THIS WAS IDENTIFIED BY BOTH SURGEONS. THE SURGEONS AND STAFF WERE CONCERNED AS THIS WAS INCONVENIENT. AT THAT TIME THE PERFORMANCE DID NOT CAUSE A CONCERN FOR PT SAFETY. ON OR ABOUT THIS TIME THE SURGERY TECHNOLOGIST CONTACTED THE MFR REPRESENTATIVE AND ASKED ABOUT THE PROBLEM WITH THE ATTACHMENT. THERE WERE RECOMMENDATIONS ON THE USE OF THE DRILL ATTACHMENTS. THE RECOMMENDATIONS WERE IMPLEMENTED BUT DID NOT AFFECT PERFORMANCE. "12/13/07", THE SURGEON TECH CALLED THE MFR AND TOLD THEM THAT THIS PROBLEM NEEDED TO BE RESOLVED. THE DISCUSSION CONCLUDED WITH AN AGREEMENT THAT INCLUDED THE TRIAL OF DIFFERENT ATTACHMENTS. THE SURGEONS INVOLVED WERE SATISFIED AS IT WAS NOT CLEAR IF IT WAS A USER ISSUE OR A PROBLEM WITH THE DEVICE. THE DRILL WAS PULLED OUT OF USE ON 01/05/07 WHEN THE CONCERNS OF THE PHYSICIANS CENTERED ON THE DRILL'S PERFORMANCE AND LETTER FROM THEM TO THE DIRECTOR OR WAS SENT INDICATING A PROBLEM WITH THE PERFORMANCE OF THE DRILL INDICATING, THE DRILL CAN DISENGAGE, TELESCOPE OUTWARD AND SPIN FOR AN INTERVAL WHILE IT LOSES MOMENTUM. IF IT IS NEAR THE DURA OR OTHER SENSITIVE STRUCTURE, THERE CAN BE SIGNIFICANT DAMAGE DONE AND IN AT LEAST ONE CASE THIS OCCURRED. (NO OTHER INJURIES HAVE BEEN REPORTED OR DETECTED.) THE SURGEONS BELIEVE THAT THIS IS WHAT OCCURRED IN THE EVENT WITH THIS PT AND THAT IT TELESCOPED FORWARD TOWARD THE DURA AND INJURED NERVE ROOTS. THERE ARE FOUR ATTACHMENTS BELIEVED TO BE IMPLICATED IN THIS EVENT. THEY HAVE THE PRODUCT NUMBER 5100-010-470. THEY WERE APPROXIMATELY 8 OTHER CASES IN WHCIH THE DRILL WAS USED PRIOR TO TAKING THE DRILL OUT OF USE. IT IS IMPOSSIBLE TO TELL IF THE ATTACHMENTS IN QUESTION WERE THE ONES THAT WERE USED AS THERE IS NO DOCUMENTATION OF THE SPECIFIC USE OF EACH ATTACHMENT AS IT RELATES TO SPECIFIC SURGICAL CASES. NO OTHER INJURIES HAVE BEEN REPORTED. THE DRILL IS NOT IN USE. THE ATTACHMENT ARE SEQUESTERED AND WILL BE TESTED BY THE MFR. THE MFR WAS NOTIFIED ON JAN 5TH BY E-MAIL. AN ADVERSE EVENT REPORT WAS GENERATED ON 01/08/07. AN AD HOC MEETING WAS CALLED ON JAN 5TH AND MET ON 01/18/07 AT 0800AM. THE EVENT WAS CONFIRMED AND DETERMINED TO BE A SENTINEL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPS ELITE LONG ATTACHMENT STRYKER CORA DRILL LONG ATTACHMENT WITH 6MM ROUND BURR HBF STRYKER INSTRUMENTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability STRYKER CORE DRILL MOTOR