BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-STANDARD

    MDR report key: 1933193 · Received December 14, 2010

    Report

    Report Number
    1719045-2010-00364
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 18, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER COULD BE EITHER 03.632.036 OR 03.632.001; LOT NUMBER COULD BE EITHER 4833405 OR 4786301. ADD'L INFO HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. INVESTIGATION IS ON-GOING. NO CONCLUSION CAN BE DRAWN AT THIS TIME. REVIEW OF MFG RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    SCREWDRIVER SLEEVES WERE DAMAGED WHEN INSERTING THE SCREWS INTO BONE. THE THREAD AT THE TIP OF THE SLEEVES BROKE OFF. IN ONE OF THE SCREWS, A PIECE OF THREAD FROM THE SLEEVE TIP FUSED TO THE SCREW HEAD. THE FRAGMENT WAS UNABLE TO BE REMOVED. THE CONSTRUCT WAS ASSEMBLED AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLDING SLEEVE-STANDARD HOLDING SLEEVE LXH SYNTHES MONUMENT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR