BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER, SHORT 3,5 MM

    MDR report key: 5517794 · Received March 22, 2016

    Report

    Report Number
    0009610622-2016-00157
    Event Type
    Malfunction
    Date Received
    March 22, 2016
    Date of Event
    February 25, 2016
    Report Date
    February 25, 2016
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SCREWDRIVER HAD BEEN SUBJECT OF A PRODUCT RECALL (2002-053) THAT HAD BEEN CARRIED OUT IN 2002. A REVIEW OF THE RECALL FILE SHOWED THAT (B)(4) UNITS OF ARTICLE 18060236 HAD BEEN DISTRIBUTED TO THE US WHEREOF (B)(4) UNITS WERE RETURNED WITHIN RECALL 2002-053. THE SUBJECT PRODUCT MUST BE ONE THE DEVICES THAT HAD NOT BEEN RETURNED UPON THE RECALL. THE DEVICE 18060236 IS NOT DISTRIBUTED ANYMORE. FURTHER INVESTIGATION IS NOT NECESSARY. VISUAL INSPECTION. THE TIP OF THE SCREWDRIVER IS BROKEN OFF COMPLETELY. THE ARTICLE NUMBER AS WELL AS THE DESIGN OF THE HEXAGON (BROKEN) OF THE TIP CONFIRMS THE DEVICE TO BE SUBJECT OF THE PRODUCT RECALL 2002-053 WHICH HAD BEEN CARRIED OUT IN 2002. THE DEVICE OBVIOUSLY HAD NOT BEEN RETURNED UPON THE RECALL. AS INVESTIGATION IN 2002 ALREADY IDENTIFIED AS DESIGN ISSUE WHICH TRIGGERED RECALL 2002-053. FURTHER DETAILED INVESTIGATION ON THIS SPECIFIC RETURNED DEVICE DEEMS NOT INDICATED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IN THE PROCESS OF SCREW REMOVAL, THE SCREW DRIVER BROKE. SALES REP WAS NOT PRESENT. ALTERNATE SCREWDRIVER WAS USED TO COMPLETE THE SCREW REMOVAL FROM A PROXIMAL R FEMORAL NAIL, NON STRYKER SYSTEM.

    Description of Event or Problem · 1

    IN THE PROCESS OF SCREW REMOVAL, THE SCREW DRIVER BROKE. SALES REP WAS NOT PRESENT. ALTERNATE SCREWDRIVER WAS USED TO COMPLETE THE SCREW REMOVAL FROM A PROXIMAL R FEMORAL NAIL, NON STRYKER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172176 SCREWDRIVER, SHORT 3,5 MM INSTRUMENT LXH STRYKER TRAUMA KIEL K721391

    Patients

    Seq Age Sex Outcome Treatment
    1 Other