BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1.1 L45/33 2FLUTE

    MDR report key: 3556277 · Received January 6, 2014

    Report

    Report Number
    2520274-2014-00022
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    December 13, 2013
    Report Date
    December 17, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    K962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: HSZ, GFA, GFF. DEVICE IS AN INSTRUMENT. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. THE REVIEW OF DEVICE HISTORY RECORDS WAS NOT PERFORMED; THE LOT NUMBER PROVIDED COULD NOT BE VERIFIED. (B)(4). 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 THE DRILL BIT 1.1 MM, LENGTH 45/33 BROKE IN SURGERY; A PORTION OF DRILL BIT STAYED IN PATIENT. IT WAS REPORTED THAT THE PATIENT HAD A FRACTURE OF THE FIRST LEFT METACARPAL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6247 DRILL BIT Ø1.1 L45/33 2FLUTE HWE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR