BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE

    MDR report key: 3584170 · Received January 21, 2014

    Report

    Report Number
    2520274-2014-00251
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Date of Event
    December 25, 2013
    Report Date
    December 26, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    PMA / PMN Number
    K951304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. HWE, HSZ, GFA, GFF: ADDITIONAL CODES. LOT 11332 WAS PROVIDED: THE NUMBER CANNOT BE VERIFIED AS A SYNTHES LOT NUMBER. 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. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE HEADLESS COMPRESSION SCREW WAS USED FOR A (B)(6) MALE WHO HAD A FRACTURE OF MALLEOLUS MEDIALIS. DURING INSERTION OF THE DRILL BIT OVER THE GUIDE WIRE, THE DRILL BIT WAS BROKEN IN PIECES 7MM FROM THE TIP. SURGEON HAD TO REMOVE ALL OF BROKEN PIECES OF THE DRILL BIT. THE CANNULATED SCREW, 4.0 MM, WAS USED AS A REPLACEMENT TO FINISH THE SURGERY WITHOUT ANY PROBLEM. REPORTEDLY THE PATIENT IS DOING WELL. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48405 DRILL BIT Ø2/1.15 CANN L150/48 3FLUTE HTW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR