BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP PROXTIBPI 3.5 LAT R SHAFT 6HO L107 T

    MDR report key: 2831366 · Received October 11, 2012

    Report

    Report Number
    3003506883-2012-00316
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Report Date
    September 12, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K030597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE INVESTIGATION FOUND THAT THE THREAD HOLES OF THE LCP PLATE CAN CUT THE USPU THREADS.

    Additional Manufacturer Narrative · 1

    THE RAW MATERIAL AND DEVICE HISTORY RECORDS WERE REVIEWED AND NOTHING WAS FOUND THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE AS RECEIVED CONDITION OF THE PLATE IS THAT THE SURFACE ANODIZE IS SLIGHTLY DISCOLORED FROM GOLD TO PINK CONSISTENT WITH NORMAL HANDLING. THERE ARE SOME SCRATCHES TO THE ANODIZED SURFACE IN THE NECK AREA OF THE PLATE AND ON THE TOP AND BOTTOM SURFACE OF THE HEAD. ALL THREADED AND NON-THREADED HOLES HAVE THE NORMAL ANODIZED SURFACE FINISH WITH NO DAMAGE EVIDENT.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL REPORTED: A RESPONSIBLE PERSON OF THE HOSPITAL FOUND THAT THREADS ON THE PLATE HOLES TEAR OFF/STRIPPED WHEN TIGHTENING. AFTER PERVADING OF THE FIBERS THROUGH THE PROXIMAL THREAD HOLES, THE FIBERS TEAR OFF WHEN TIGHTENING. THERE WAS NO PATIENT INVOLVEMENT. THIS IS 11 OF 13 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCP PROXTIBPI 3.5 LAT R SHAFT 6HO L107 T LCP PROXTIBPLATE HRS SYNTHES ELMIRA 6724800

    Patients

    Seq Age Sex Outcome Treatment
    1