BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK PRODUCT - DRILL

    MDR report key: 2192491 · Received June 30, 2011

    Report

    Report Number
    9610622-2011-00286
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 14, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. ADD'L INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE FOLLOWING HAS BEEN REPORTED BY THE SURGEON, GUIDE WIRE AND 360 DRILL WENT PROXIMALLY THROUGH THE HOLE IN THE NAIL. IN A SUBSEQUENT COMMUNICATION WITH THE SALES REP (WHO ATTENDED THE CASE) VIA E-MAIL, THE FOLLOWING INFO WAS RENDERED: "THE K WIRE AND THE 4.2 MM X 360 MM DRILL SEEMED TO DEFLECT ONCE GOING THROUGH THE HOLE IN THE NAIL. THEY SPENT QUITE A BIT OF TIME TYPING TO GET IT IN THE RIGHT PLACE AND THEN REAMED WITH THE STEP DRILL BY HAND. THE STEP DRILL DIDN'T APPEAR TO HIT THE NAIL STRAIGHT. I'VE SEEN THE K-WIRE DEFLECT BUT NOT THE DRILL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK PRODUCT - DRILL INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other