BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED SCREWDRIVER ASNIS III HEX 2.5MM ELASTO

    MDR report key: 1981639 · Received January 12, 2011

    Report

    Report Number
    8031020-2011-00006
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    November 8, 2010
    Report Date
    December 21, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HWC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS BEING RETAINED BY THE HOSPITAL. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER, REPORTED VIA THE (B)(6) THAT WHILE THE SURGEON WAS INSERTING A SCREW INTO A PLATE, THE HEAD OF THE SCREWDRIVER SNAPPED INTO THE HEAD OF THE SCREW. THE CUSTOMER FURTHER ALLEGED THAT THE TOOTHPICK ALSO SNAPPED WHILE IN USE. THE CUSTOMER ADDED THAT THE SURGEON ATTEMPTED TO REMOVE BOTH PARTS OF THE INSTRUMENTS, BUT THEY WERE UNSUCCESSFUL. THE CUSTOMER FURTHER REPORTED THAT IT WILL BE DIFFICULT TO REMOVE THE SCREW, SHOULD THIS BE REQUIRED IN THE FUTURE AND THAT IT WILL NEED TO BE REMOVED FROM THE OTHER SIDE OF THE BONE. NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED SCREWDRIVER ASNIS III HEX 2.5MM ELASTO INSTRUMENT HWC STRYKER OSTEOSYNTHESIS SELZACH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other