BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE Ø1.6 W/DOUB TIP L150 SST

    MDR report key: 2940970 · Received February 4, 2013

    Report

    Report Number
    2520274-2013-00752
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    December 20, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    LRN
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THE WIRES HAVE A SLIGHT BROWNISH DISCOLORATION ON ONE SIDE. AS MENTIONED ABOVE THE WIRES HAVE JUST ON ONE SIDE THE COMPLAINED DISCOLORATION AND THIS COLORATION CAN BE REMOVED WITH A BRUSH. ACCORDING TO THE COMPLAINT DESCRIPTION THE WIRES WERE STORED IN A STERILE POUCH FROM THE HOSPITAL OVER SEVERAL MONTHS. THIS LET US ASSUME THAT THE WIRES WERE NOT PACKED COMPLETELY DRY, WHICH CAN HAVE AN INFLUENCE CHROMIUM OXIDE LAYER AND CAN LEAD TO CONTACT CORROSION. NO MANUFACTURING RELATED FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED THAT K-WIRES WERE FOUND TO BE PARTIALLY DISCOLORED. THIS PROBLEM WAS DETECTED BEFORE A PROCEDURE. WIRES PRESENTED REMAINS OF OXIDE. LOT NUMBERS CANNOT BE PROVIDED BECAUSE THE HOSPITAL STOCKS WIRES TOGETHER. WIRES WERE STOCKED IN A STERILE POUCH OVER SEVERAL MONTHS. IT IS REPORTED THAT DISCOLORATION IS ONLY PRESENT ON ONE SIDE OF THE WIRES AND CAN BE EASILY REMOVED WITH A BRUSH. THIS IS 1 OF 5 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46222 K-WIRE Ø1.6 W/DOUB TIP L150 SST K-WIRE LRN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1