BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1.8 W/MARKING L110/85 2FLUTE

    MDR report key: 3170108 · Received June 14, 2013

    Report

    Report Number
    2520274-2013-03475
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 17, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT PRESENTED WITH DISTAL RADIUS FRACTURE. DURING THE PROCEDURE ON (B)(6) 2013, REPORTEDLY THE DRILL BIT BROKE. IT WAS REPORTED BEFORE THE BREAKAGE, THE DRILL BIT CAME INTO CONTACT WITH THE TEMPORARY FIXED K-WIRE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271881 DRILL BIT Ø1.8 W/MARKING L110/85 2FLUTE HTW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR