BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERIS

    MDR report key: 589084 · Received April 6, 2005

    Report

    Report Number
    MW1035115
    Event Type
    Malfunction
    Date Received
    April 6, 2005
    Date of Event
    March 9, 2005
    Report Date
    March 31, 2005
    Manufacturer
    VILEX
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PLACING 0.62 K-WIRE IN BONE, PORTION OF K-WIRE BROKE. PHYSICIAN UNABLE TO REMOVE RETAINED PORTION OF WIRE. DETERMINED THAT WIRE WOULD NOT INTERFERE WITH DESIRED MOVEMENT.

    Description of Event or Problem · 1

    A REPORT HAS NOT BEEN FILED WITH VILEX BY THE CUSTOMER (DOCTOR OR HOSPITAL). AN ACCOUNTING OF ALL STAINLESS STEEL .062 X 6" K-WIRES SOLD (K16150-12N AND K16150-05S) FOR THE PAST THREE YEARS HAS BEEN DONE. CO HAS NOTED THIS CASE IN THE COMPLAINT FILE. THE CASE IS UNIQUE AND CO DO NOT KNOW THE CASE CIRCUMSTANCES THAT WOULD CAUSE A 0.062 WIRE TO BREAK. CO HAVE DETERMINED THAT ACTION ON THE CO'S PART IS NOT NECESSARY SINCE 1025 OF THIS SIZE AND LOT NUMBER WERE SOLD. WHEN THE MATERIAL IS RECEIVED, VILEX DOES NOT ALTER IT IN ANY WAY THAT WOULD CAUSE CA CHANGE IN THE STRENGTH. THE WIRES WERE SOLD BETWEEN AUG 2003 AND NOV 2004. IT HAS BEEN ALMOST SEVEN MONTHS SINCE THE LAST WIRES WERE SOLD AND CO FEEL THAT OUT OF 1025 WIRES OF THIS ONE SIZE (CO HAD OVER 3,000 TOTAL WIRES SOLD OUT OF THE SAME BATCH NUMBER IN OTHER SIZES) CO SHOULD HAVE HAD MORE REPORTS IF THERE WAS, IN FACT, A PROBLEM WITH MATERIAL. CO'S DETERMINATION IS THAT A MEDICAL DEVICE REPORT (MDR) IS NOT NECESSARY SINCE CO HAS NOT BEEN CONTACTED BY THE USER AND CO DO NOT KNOW THE CIRCUMSTANCES SURROUNDING HOW THE PRODUCT WAS USED. ALL LOT NUMBERS, LOT # 1010940. SALES MAY 1, 2002-APRIL 30, 2003 = 1,052 WIRES SOLD 0; SALES MAY 1, 2003 - APRIL 30, 2004 = 1,036 WIRES SOLD 696; SALES MAY 1, 2004 - APRIL 30, 2005= 1,067 WIRES SOLD 329.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS K-WIRE WITH GUARDS .062 X 6" HTY VILEX K16150-055 1010940

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other