BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE 1.0MMX750XX W/CRIMP

    MDR report key: 6185405 · Received December 14, 2016

    Report

    Report Number
    MW5066750
    Event Type
    Malfunction
    Date Received
    December 14, 2016
    Date of Event
    December 13, 2016
    Report Date
    December 14, 2016
    Manufacturer
    SYNTHES INC.
    Product Code
    JDQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING OPEN TREATMENT OF THE LEFT CLOSED PATELLAR FRACTURE WITH PARTIAL PATELLECTOMY AND OPEN REDUCTION, INTERNAL FIXATION AS TREATMENT FOR A CLOSED LEFT COMMINUTED STELLATE PATELLAR FRACTURE. UPON POSITIONING OF THE GUIDEWIRE (PART OF THE SYNTHES CANNULATED SCREW SYSTEM), THE TIP OF THE GUIDEWIRE BROKE. THE SURGEON ATTEMPTED MULTIPLE TIMES TO RETRIEVE THE TIP BUT WAS UNSUCCESSFUL. AT THAT TIME, IT WAS DECIDED TO LEAVE THE TIP IN THE BONE AS FURTHER ATTEMPTS TO RETRIEVE IT WOULD HAVE CAUSED ADDITIONAL INJURY TO THE PATELLA. THERE WAS NO INJURY TO THE PATIENT NOR DID THIS PRODUCT ISSUE CAUSE A PROLONGED LENGTH OF STAY. BECAUSE THERE WERE 2 OF THESE GUIDEWIRES USED DURING THIS PROCEDURE, THERE ARE 2 LOT NUMBERS BUT WE ARE UNABLE TO DETERMINE WHICH LOT # IS ASSOCIATED WITH THE WIRE THAT BROKE. BOTH LOT NUMBERS ARE: P214134 AND P226664. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824034 CABLE 1.0MMX750XX W/CRIMP GUIDEWIRE JDQ SYNTHES INC. 298.800.01S 9214134

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR