BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE-STEP INSERTION WRENCH OMEGA

    MDR report key: 2925790 · Received January 22, 2013

    Report

    Report Number
    0008031020-2013-00002
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    HXC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED INCIDENT COULD NOT BE CONFIRMED. DEVICE CONFORMING TO SPECIFICATION.REPORTED EVENT COULD NOT BE REPRODUCED. DEVICE HISTORY FOR REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS INSERTING THE LAG SCREW FOR AN OMEGA 3 AND THE PLATE WOULD NOT SLIDE OVER THE MODULAR ONE STEP INSERTION WRENCH. SURGEON THOUGHT THE WRENCH MUST HAVE BEEN BENT. EITHER DURING THE SURGERY OR BEFORE IS UNKNOWN. DELAYED THE CASE FOR 10-15 MIN, TOOK EVERYTHING OUT AND USED THE OLDER KEY HANDLE TO INSERT THE LAG SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS INSERTING THE LAG SCREW FOR AN OMEGA 3 AND THE PLATE WOULD NOT SLIDE OVER THE MODULAR ONE STEP INSERTION WRENCH. SURGEON THOUGHT THE WRENCH MUST HAVE BEEN BENT. EITHER DURING THE SURGERY OR BEFORE IS UNKNOWN. DELAYED THE CASE FOR 10-15 MIN, TOOK EVERYTHING OUT AND USED THE OLDER KEY HANDLE TO INSERT THE LAG SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30896 ONE-STEP INSERTION WRENCH OMEGA INSTRUMENT HXC STRYKER OSTEOSYNTHESIS-SELZACH W15597

    Patients

    Seq Age Sex Outcome Treatment
    1 Other