BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0 MM CANCELLOUS SCREW FULLY THREADED 55 MM LENGTH

    MDR report key: 1587547 · Received January 13, 2010

    Report

    Report Number
    2648920-2010-00001
    Event Type
    Malfunction
    Date Received
    January 13, 2010
    Date of Event
    December 1, 2009
    Report Date
    December 18, 2009
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    KTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT IS UNK WHAT TYPE OF LOADING THE SCREW WAS SUBJECTED TO DURING SURGERY (I.E. BENDING MOMENT LOADS) THAT MAY HAVE RESULTED IN THE DEVICE TO FRACTURE. NO OPERATIVE NOTES WERE RETURNED FOR REVIEW. BASED ON THE AVAILABLE INFO A DEFINITIVE ROOT CAUSE CAN NOT BE ASCERTAINED AT THIS TIME. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT ON (B) (6) 2009, A SCREW WAS INSERTED TO REDUCE THE SEPARATION OF THE SYNDESMOSIS. DURING SURGERY OF REDUCTION OF DISTAL FIBULA FRACTURE, THE SCREW BROKE JUST BELOW THE HEAD OF THE SCREW. THIS HAPPENED AFTER THE MANUAL INSERTION AND AFTER THE FLUOROSCOPIC CONTROL OF THE RIGHT POSITION OF THE SCREW AND DURING THE MANUAL CONTROL OF CORRECT TIGHTENING. THE SCREW WAS LEFT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0 MM CANCELLOUS SCREW FULLY THREADED 55 MM LENGTH TRAUMA PROSTHESIS KTT ZIMMER MANUFACTURING B.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR