BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSA-FX LINKED LAG SCREW INSERTER

    MDR report key: 2081981 · Received April 5, 2011

    Report

    Report Number
    1822565-2011-00836
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: NO SURGICAL NOTES WERE PROVIDED WHICH INDICATE HOW THE INSTRUMENT WAS BEING USED WHEN THE EVENT OCCURRED. THE LOAD AND ANGLE OF INSERTION AT THE TIME OF BREAKAGE ARE UNK. RESEARCH ANALYSIS PREVIOUSLY CONDUCTED FOUND IF THE INSERTER DRIVE LINK IS NOT FULLY ENGAGED WITH THE LAG SCREW, THERE IS AN INCREASED RISK OF FRACTURE OF THE INSTRUMENT. IT IS NOT KNOWN IF THE SURGICAL TECHNIQUE WAS BEING FOLLOWED. POTENTIAL FIELD AGE OF THE INSERTER SHAFTS IS 7 YEARS. WITH THE INFO PROVIDED, THE EXACT CAUSE OF THIS EVENT CANNOT BE DEFINITIVELY DETERMINED. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MFG AND INSPECTED TO SPECIFICATION. DIMENSIONAL ANALYSIS FOUND MEASUREMENTS TAKEN TO BE WITHIN SPECIFICATION. NO MFG ABNORMALITIES COULD BE DETECTED BY EITHER METHOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FEMORAL ORIF PROCEDURE, THE END OF THE INSERTER SHAFT BROKE OFF WHILE INSERTING THE COMPRESSION SCREW. THIS OCCURRED TWICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSA-FX LINKED LAG SCREW INSERTER TRAUMA INSTRUMENT LXH ZIMMER, INC. 60178669

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT #58009400| INSERTER DRIVE SHAFT: CATALOG #00119301202,| VERSA-FX FEMORAL FIXATION SYSTEM REPLACEMENT| VERSA-FX FEMORAL FIXATION SYSTEM REPLACEMENT| INSERTER DRIVE LINK: CATALOG #00119301201,| LOT #60125589