BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8MM DRILL BIT WITH DEPTH MARK/QC/110MM

    MDR report key: 2192597 · Received July 1, 2011

    Report

    Report Number
    8030965-2011-00302
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Report Date
    June 7, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. INVESTIGATION CO-ORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THAT THE TIP OF THE DRILL BIT PARTIALLY BROKE OFF. THE MICROSCOPIC VIEW OF THE BROKEN SURFACE DOES NOT SHOW ANY ANOMALIES OF THE MATERIAL QUALITY. THE AVAILABLE DIMENSIONS WERE CHECKED AND FOUND TO BE WITHIN SPECIFICATION. FURTHER INVESTIGATION REGARDING THE MFG AND RAW MATERIAL DOCUMENTS SHOWS CONFORMITY TO THE SPECIFICATION. NO PRODUCT OR MATERIAL FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    THE 1.8 MM DRILL BIT BROKE WHILE DRILLING IN BONE. BROKEN BIT WAS LEFT IN PT'S BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.8MM DRILL BIT WITH DEPTH MARK/QC/110MM QUICK COUPLING DRILL BIT HTW SYNTHES GMBH NA 2658836

    Patients

    Seq Age Sex Outcome Treatment
    1 NI