BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø3.2 L130/115 2FLUTE

    MDR report key: 3556288 · Received January 6, 2014

    Report

    Report Number
    2520274-2014-00023
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    December 9, 2013
    Report Date
    December 12, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE HSZ. DEVICE IS AN INSTRUMENT. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF DEVICE HISTORY RECORDS WAS NOT PERFORMED THE LOT NUMBER WAS NOT PROVIDED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6); THAT DURING THE SURGERY ON (B)(6) 2013 DURING DRILLING THE HOLE IN THE BONE, THE DRILL BIT HITS THE PLATE AND BREAKS; THE DRILL BIT DIDN'T COME IN CONTACT WITH THE BONE. IT WAS REPORTED THAT THE REMAINS WERE SCRAPPED IN THE HOSPITAL. NO PATIENT HARM. PATIENT HAD FRACTURE OF PROXIMAL TIBIA. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5681 DRILL BIT Ø3.2 L130/115 2FLUTE HTW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR