BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE MULTI-PIN CLAMP 6 POSITION

    MDR report key: 3063634 · Received April 17, 2013

    Report

    Report Number
    2530088-2013-00625
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    KTT
    PMA / PMN Number
    K082650
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DHR WAS REVIEWED AND NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS LOT HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT ON (B)(6) 2013. ON (B)(6) 2013 PATIENT WAS IMPLANTED WITH A LARGE X-FIX FOR DISTAL TIBIA FRACTURE. ON (B)(6) 2013, PATIENT WAS IMPLANTED WITH LOCKING COMPRESSION PLATE AND SCREW CONSTRUCT FOR HUMERUS FRACTURE. IT WAS REPORTED THAT BEFORE THE SECOND SURGERY, AS TECH ATTEMPTED TO REMOVE THE X-FIX MULTI PIN CLAMP FOR A WOUND VACUUM, THE SPRING AND BOLT INSIDE THE MULTI CLAMP POPPED OUT. SURGEON LEFT THE ORIGINAL CLAMP AND SCHANZ SCREWS, AND RE-SECURED CONSTRUCT WITH A NEW CARBON ROD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166117 LARGE MULTI-PIN CLAMP 6 POSITION KTT SYNTHES BRANDYWINE 6987030

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR