BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT

    MDR report key: 2760728 · Received September 20, 2012

    Report

    Report Number
    2520274-2012-01976
    Event Type
    Malfunction
    Date Received
    September 20, 2012
    Date of Event
    August 15, 2012
    Report Date
    August 23, 2012
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A PATELLAR FRACTURE PROCEDURE AFTER THE DOCTOR INSERTED THE GUIDE WIRE 1.1MM FOR 3.0HCS, THE DRILL 2.0MM WAS DAMAGED AND THE GUIDE WIRE WAS BENT. SURGEON TRIED A NEW DRILL BIT AND WIRE WITH THE TIP OF THE DRILL DAMAGED AGAIN ALONG WITH THE WIRE, WHICH WAS IN THE PATIENT'S BONE. SURGEON DID RETRIEVE THE WIRE FROM INSIDE THE PATIENT'S BONE. SURGEON DID DRILL THE HOLE USING K-WIRE, INSERTED THE SCREW AND FINALIZED THE OPERATION. THIS IS 3 OF 4 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL BIT HTW

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR DRILL BIT| GUIDE WIRE| PIN/WIRE