BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 2120413 · Received May 27, 2011

    Report

    Report Number
    8030965-2011-00254
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Report Date
    May 17, 2011
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWC
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE WAS NOT EXPLANTED. UNABLE TO PROVIDE THE MANUFACTURER, PMA/510K NUMBER AND/OR THE DATE OF THE MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO PART/LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO PART/LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A DEVICE REPORT RECEIVED FROM (B)(4) INDICATES AN (B)(4) STUDY IN (B)() REPORTED: DURING A PROCEDURE ON AN UNKNOWN DATE SURGEON WAS INSERTING TWO SCREWS, A 2.7 CORTEX AND A 2.7 LOCKING SCREW, AND BOTH SCREWS BROKE. SURGEON DID NOT RETRIEVE THE SHAFTS, BOTH SCREW SHAFTS REMAIN IN THE PATIENT'S BONE. THIS IS TWO OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI LOCKING SCREW HWC SYNTHES OBERDORF NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI CORTEX SCREW