BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TC BABY-CRILE-WOOD NDL HLDR SERR 150MM

    MDR report key: 3196805 · Received June 25, 2013

    Report

    Report Number
    2916714-2013-00040
    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: 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. DESPITE SEVERAL REQUESTS WE DID NOT RECEIVE INFO REGARDING THE PT'S CONDITION.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE TIP OF THE NEEDLE HOLDER BROKE OFF INTRAOPERATIVELY. THE POSSIBILITY, THAT THE TIP FELL INTO THE PT CANNOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287361 TC BABY-CRILE-WOOD NDL HLDR SERR 150MM HXK AESCULAP AG & CO KG BM013R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other