BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER STRAIGHT SCREWDRIVER SHANK

    MDR report key: 3954795 · Received July 18, 2014

    Report

    Report Number
    1822565-2014-00890
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    HXX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL FREQUENCY OF USE IS UNKNOWN. SEM ANALYSIS DETERMINED THAT THE FRACTURE OCCURRED DUE TO OVERLOAD. HIGHER THAN ANTICIPATED FORCES COULD HAVE BEEN POSED ON THE HEX FEATURE IF THE PROVISIONAL LINER LOCKING SCREW WAS CROSS THREADED OR OVER TIGHTENED, HOWEVER, NEITHER OF THESE SCENARIOS CAN BE CONFIRMED AS THE ROOT CAUSE. THE SCREWDRIVER'S FIELD AGE MAY HAVE ALSO CONTRIBUTED TO THE FRACTURE EVENT. THE SCREWDRIVER MET PRINT SPECIFICATIONS WHERE MEASURED, INCLUDING THE ROCKWELL HARDNESS TEST. THERE ARE NO PREVIOUS COMPLAINTS AGAINST THE MANUFACTURING LOT OF THE SCREWDRIVER. CAUSE CANNOT BE DEFINITIVELY DETERMINED. THE SCREWDRIVER IS RETURNED FOR REVIEW, ALONG WITH THE PROVISIONAL LINER, SHELL AND LINER. THE FRACTURE SURFACE OF THE SCREWDRIVER WAS ANALYZED USING A SCANNING ELECTRON MICROSCOPE DEVICE. HISTORY RECORDS INDICATE THE SCREWDRIVER WAS MANUFACTURED AND INSPECTED TO SPECIFICATION. (SEM) AS WELL AS ENERGY DISPERSIVE SPECTROSCOPY (EDS). EDS ANALYSIS DETERMINED THAT THE MATERIAL WAS CONSISTENT WITH 440A STAINLESS STEEL, WHICH IS ACCORDING TO PRINT SPECIFICATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON IMPLANTED A SHELL. THE TRIAL LINER WAS THEN INSTALLED. THE SCREWDRIVER TIP BROKE IN THE LOCKING SCREW CAUSING THE SURGEON TO SECTION THE TRIAL LINER OUT OF THE CUP. THIS PROCESS DAMAGED THE SHELL. THE SURGEON THEN TRIED TO IMPLANT A LINER, BUT THE LINER WOULD NOT SEAT CORRECTLY DUE TO THE DAMAGED SHELL; THE CUP HAD TO BE REMOVED. THE SURGERY WAS DELAYED FOR THREE HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423075 ZIMMER STRAIGHT SCREWDRIVER SHANK HXX ZIMMER, INC. 60361471

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other