BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASSIER-DUVAL TELESCOPIC IM SYSTEM

    MDR report key: 3829600 · Received April 17, 2014

    Report

    Report Number
    3000327445-2014-00002
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    January 29, 2013
    Report Date
    April 18, 2014
    Manufacturer
    PEGA MEDICAL INC.
    Product Code
    HSB
    PMA / PMN Number
    041393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED ON (B)(6) 2013, THIS REPORT IS BEING SUBMITTED AFTER REVIEW OF CUSTOMER COMPLAINTS. THIS REVIEW IS PART OF A CORRECTIVE ACTION ISSUED AFTER WARNING LETTER ON 01/2014. THE FEMALE DRIVER IS THE INSTRUMENT USED TO INSERT THE FEMALE COMPONENT OF THE FASSIER-DUVAL SYSTEM INTO THE MEDULLARY CANAL. MFG INFO RELATED TO THIS LOT WAS REVIEWED TO DETERMINE IF THERE WAS ANY MFG PROBLEM THAT COULD HAVE EXPLAIN THIS FAILURE. MATERIAL, HEAT TREATMENT AND DIMENSIONS WERE MADE ACCORDING TO SPECIFICATIONS. THIS PART WAS SENT TO THE CUSTOMER ON (B)(4) 2009. SINCE THEN, THIS DEVICE HAS BEEN USED MANY SURGERIES WITHOUT A PROBLEM. THIS FACT MAY CONFIRM THAT THERE WERE NO MFG PROBLEMS RELATED TO THIS DEVICE. THIS IS NOT A DEVICE SUBMITTED TO CYCLIC STRESSES, THEREFORE, FATIGUE FAILURE IS NOT POSSIBLE. THE ORIGIN OF THIS BREAKAGE CAN NOT BE CONCLUDED WITH CERTAINTY. THIS TYPE OF FAILURE HAS HAPPENED IN THE PAST. IN MOST OF THE CASES, IT WAS SUSPECTED THAT THE APPLICATION OF BENDING MOMENTS DURING THE INSERTION OF THE FEMALE COMPONENT WAS THE CAUSE OF FAILURE. THERE IS A WARNING ALREADY INDICATED IN THE SURGICAL TECHNIQUE. THE METHOD OF MFG OF THE DEVICE HAS BEEN ALSO IMPROVED DURING THE LAST YEARS IN ORDER TO OBTAIN BETTER CONCENTRICITY BETWEEN THE HEXAGONAL TIP AND THE HOLE WHICH MAKES THE INSTRUMENT STRONGER.

    Description of Event or Problem · 1

    THE FEMALE DRIVER BROKE WHILE INSERTING THE FEMALE COMPONENT IN A FEMUR. THEY WERE TRYING TO ADVANCE THE THREAD DEEPER IN THE BONE. THE BONE WAS NOT REGARDED AS PARTICULARLY HARD. THE SURGERY WAS COMPLETED AND THEY ACCEPTED THE DEPTH THAT THE FD HAD ALREADY BEEN ADVANCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235305 FASSIER-DUVAL TELESCOPIC IM SYSTEM FD NAIL HSB PEGA MEDICAL INC. FEMALE DRIVER 271129-02

    Patients

    Seq Age Sex Outcome Treatment
    1