BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5 CANCELLOUS BONE SCREW 45MM

    MDR report key: 4671899 · Received April 9, 2015

    Report

    Report Number
    0002249697-2015-01115
    Event Type
    Malfunction
    Date Received
    April 9, 2015
    Date of Event
    March 12, 2015
    Report Date
    March 13, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HWC
    PMA / PMN Number
    K894124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DAMAGE INVOLVING A CANCELLOUS BONE SCREW AND TRIDENT SHELL (PR 800766) WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: THE BONE SCREW WAS NOT RETURNED FOR ANALYSIS, HOWEVER THE METAL FRAGMENT WAS RETURNED. A TECHNICAL REPORT CONCLUDED THAT THE METAL FRAGMENT WAS APPROXIMATELY 50MM IN LENGTH WHEN UN-COILED. EXAMINATION OF THE METAL FRAGMENT SHOWED THE COMPOSITION OF THE FRAGMENT TO BE CONSISTENT WITH THAT OF (B)(4). BOTH THE TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL AND THE CANCELLOUS BONE SCREW ARE BOTH MANUFACTURED FROM (B)(4) SO ARE BOTH POTENTIAL CANDIDATES AS A SOURCE OF THE METAL FRAGMENT. NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. A COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED. ANALYSIS OF THE SCREW AND THE SHELL ARE REQUIRED TO CONFIRM WHICH DEVICE THE METAL SHARD CAME FROM AND THE POTENTIAL CAUSE. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION AND/OR DEVICES BECOME AVAILABLE THIS INVESTIGATION SHALL BE REOPENED.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THEY WERE INSERTING A TRIDENT CUP AND SCREW, THE CUP WAS INSERTED AS NORMAL AND THE TEAM PREPPED FOR THE SCREW AS NORMAL. WHEN THE SCREW WAS INSERTED, THEY ALLEGEDLY NOTICED A SHARD OF METAL. THE SCREW WAS LEFT IN SITU. THE CUSTOMER FURTHER REPORTED THAT THE METAL WAS RECOVERED AND THERE WAS NO PATIENT INJURY. THE CUSTOMER BELIEVES THAT THE METAL MAY BE FROM THE SCREW. THE PIECE HAS BEEN RETAINED AND WILL BE RETURNED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THEY WERE INSERTING A TRIDENT CUP AND SCREW, THE CUP WAS INSERTED AS NORMAL AND THE TEAM PREPPED FOR THE SCREW AS NORMAL. WHEN THE SCREW WAS INSERTED THEY ALLEGEDLY NOTICED A SHARD OF METAL. THE SCREW WAS LEFT IN SITU. THE CUSTOMER FURTHER REPORTED THAT THE METAL WAS RECOVERED AND THERE WAS NO PATIENT INJURY. THE CUSTOMER BELIEVES THAT THE METAL MAY BE FROM THE SCREW. THE PIECE HAS BEEN RETAINED AND WILL BE RETURNED. THE CUSTOMER REPORTED THAT THERE WAS NO DELAY TO SURGERY OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234755 6.5 CANCELLOUS BONE SCREW 45MM IMPLANT HWC STRYKER ORTHOPAEDICS-MAHWAH MNJM0T

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other