BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRAFIX BAR TO PIN CLAMP

    MDR report key: 6094117 · Received November 10, 2016

    Report

    Report Number
    0001822565-2016-04130
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 18, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    KTT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. ITEM# 00-5200-010-01 WAS TEST ASSEMBLED TO A 00-5203-011-50 CARBON FIBER BAR IN BOTH CLAMPS AND TIGHTENED WITH THE APPROPRIATE 00-5210-009-04 T-HANDLE 9MM HEX. THIS ITEM SECURELY LOCKED ON IN BOTH CLAMP ENDS, AND RELEASED AS INTENDED DURING DISASSEMBLY. ALL OF THE RETURNED ITEM NUMBERS 00-5200-010-02 WERE TEST ASSEMBLED TO A 00-5203-011-50 CARBON FIBER BAR, 00-5204-050-55 HALF-PIN & 00-5204-060-55 HALF-PIN AND TIGHTENED WITH THE APPROPRIATE 00-5210-009-04 T-HANDLE 9MM HEX. THESE ITEMS SECURELY LOCKED ON IN BOTH CLAMP ENDS, AND RELEASED AS INTENDED DURING DISASSEMBLY. MANUAL ACTUATION OF MOVABLE COMPONENTS INDICATED THAT THE MOVABLE COMPONENTS OF THE ITEMS OPERATED THROUGH THE FULL RANGE OF THE INTENDED MOTION AND I COULD NOT REPLICATE THE ALLEGED DEFICIENCY. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS INDICATED THAT THE DEVICES MET SPECIFICATIONS AT THE TIME OF MANUFACTURE. THESE DEVICES ARE USED FOR TREATMENT. THE MOST LIKELY CAUSE OF THE CLAMPS REPORTABLY NOT MOVING FREELY CANNOT BE DETERMINED AS THE PROBLEM WAS NOT REPRODUCED.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. RETURNED, NOT YET EVALUATED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE CLAMPS WOULD NOT FREELY ROTATE ABOUT THEIR RANGE OF MOTION AS THEY SHOULD. PRODUCT WAS PULLED FROM CONSIGNMENT PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745061 XTRAFIX BAR TO PIN CLAMP TRAUMA IMPLANT KTT ZIMMER, INC. 56548632

    Patients

    Seq Age Sex Outcome Treatment
    1