BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3781404 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01584
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN TS AUGMENT SCREWDRIVER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DAMAGE INVOLVING AN UNKNOWN DRIVER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. CONCLUSIONS: NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    DURING REIMPLANTATION THE SCORPIO TS AUGMENT SCREWDRIVER STRIPPED MAKING IT DIFFICULT TO TIGHTEN SCREWS. CAUSED A LESS THAN FIVE MINUTE DELAY.

    Description of Event or Problem · 1

    DURING REIMPLANTATION THE SCORPIO TS AUGMENT SCREWDRIVER STRIPPED MAKING IT DIFFICULT TO TIGHTEN SCREWS. CAUSED A LESS THAN FIVE MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260117 UNKNOWN_RECONSTRUCTIVE_PRODUCT INSTRUMENT HXX STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other