BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASSIER-DUVAL TELESCOPIC IM SYSTEM

    MDR report key: 1884168 · Received September 20, 2010

    Report

    Report Number
    3000327445-2010-00001
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 20, 2010
    Report Date
    September 13, 2010
    Manufacturer
    PEGA MEDICAL
    Product Code
    HSB
    PMA / PMN Number
    041393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION REPORTS, MATERIAL AND PROCESS CERTIFICATES SHOWED THAT THIS DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE DESIGN OF THE DEVICE IS NOT OF CONCERN SINCE THIS DEVICE HAS BEEN ON THE MARKET OVER 10 YRS. THIS TYPE OF DEVICES HAS BEEN USED IN SEVERAL THOUSAND SURGERIES AND THIS IS THE FIRST TIME OCCURRENCE. THE FAILED DEVICE WAS USED IN 11 SURGERIES PRIOR TO THIS FAILURE. PEGA MEDICAL REP WAS PRESENT AT THE SURGERY WHERE IT FAILED AND HE DID NOT OBSERVE ANY UNUSUAL FORCE APPLIED ON THE INSTRUMENT BEFORE BREAKAGE. THEREFORE, IT IS SUSPECTED THAT THE DEVICE HAD AN INHERENT CRACK OR DEFECT PRIOR TO THE SURGERY. THIS DEFECT COULD HAVE BEEN CAUSED BY A PREVIOUS MISUSE, SUCH AS DRILLING ON METAL (FRICTION WITH OTHER INSTRUMENTS) OR USE OF THE DEVICE FOR ANOTHER PURPOSE, OR BY ACCIDENTAL IMPACT.

    Description of Event or Problem · 1

    PT UNDERGOING BILATERAL FEMORAL OSTEOTOMIES WITH INTRAMEDULLARY NAIL FOR INTERNAL FIXATION PROCEDURE, USING FASSIER-DUVAL TELESCOPIC IM SYSTEM. DRILL BIT TIP BROKE. X-RAY CONFIRMED DRILL BIT TIP WAS IN RIGHT FEMUR. THE DRILL BIT WAS LEFT IN THE PT, AS RETRIEVAL EFFORT COULD CAUSE MORE HARM TO THE PT. THE DRILL IS USED TO REAM THE INTRAMEDULLARY CANAL OF THE BONE TO THE APPROPRIATE SIZE PRIOR TO THE INSERTION OF THE NAIL. THE DRILL BROKE DURING THE REAMING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FASSIER-DUVAL TELESCOPIC IM SYSTEM ROD, FIXATION, INTRAMEDULLARY AND ACCESS HSB PEGA MEDICAL 290911-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other