BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TC BABY-CRILE-WOOD NDL HLDR SERR 150MM

    MDR report key: 3196790 · Received June 25, 2013

    Report

    Report Number
    2916714-2013-00039
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Report Date
    May 22, 2013
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    HXK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: INSTRUMENT WAS REPAIRED AT ATS (DE) IN 2013. NEEDLE HOLDERS WHICH HAVE BEEN REPAIRED, SHOW A LITTLE BIGGER TENDENCY TO BREAK THAN BRAND NEW ONES, IF THE CARBIDE METAL WAS CHANGED. THIS PROBLEM IS WELL KNOWN TO US. BUT NEVERTHELESS EVEN THE STRENGTH OF A REPAIRED NEEDLE HOLDER IS STRONG ENOUGH TO LAST WITH PROPER HANDLING. WHETHER THE HANDLING WAS IMPROPER OR NOT CANNOT BE ASCERTAINED. IT CONCERNS A FORCED FRACTURE CAUSED BY A MECHANICAL OVERLOAD SITUATION.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). TIP OF NEEDLE HOLDER BROKE DURING SURGERY. ACCORDING TO THE ASSISTING NURSE THE FRAGMENT OF THE TIP FELL INTO THE PT BUT COULD BE FOUND WITHOUT ANY TIME DELAY, NO CONSEQUENCES FOR THE PT. THE FRAGMENT WAS SCRAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287416 TC BABY-CRILE-WOOD NDL HLDR SERR 150MM HXK AESCULAP AG & CO. KG BM013R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other