BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL HIP MODULAR FLEX DRILL BIT

    MDR report key: 2182264 · Received July 12, 2011

    Report

    Report Number
    1822565-2011-01632
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS REC'D FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: IT IS UNK IF A DRILL GUIDE WAS USED WHEN DRILLING INTO THE BONE. A DRILL BIT FRACTURE CAN BE CAUSED BY ONE OR MORE OF THE FOLLOWING: EXCESSIVE FORCE APPLIED DURING USAGE. CONTINUED OPERATION OF THE DRILL AFTER IT WAS STUCK AGAINST HARD MATERIAL. RAPID REVERSAL OF DIRECTION OF ROTATION WHEN THE DEVICE IS STUCK. EXCESSIVE BENDING. DEVICE WERE DUE TO USAGE WITH TIME. LOW SPEED / HIGH TORQUE OF OPERATION. BASED ON THE INFO PROVIDED, A DEFINITIVE CAUSE FOR THE FRACTURE CANNOT BE DETERMINED WITH CERTAINTY. EVAL: AS RETURNED, THE DRILL BIT IS FRACTURED IN THE FLUTED PORTION APPROX ONE INCH FROM THE TIP. THE BIT EXHIBITS HEAVY GOUGES ON THE FLUTES. MATERIAL HARDNESS WAS FOUND TO BE WITHIN SPECIFICATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND TO BE CONFORMING TO THE MFG, INSPECTION, AND PACKAGING SPECIFICATIONS. SCANNING ELECTRON MICROSCOPY WAS PERFORMED ON THE FRACTURE SURFACE. THE SURFACE INDICATES THE EVENT MAY HAVE OCCURRED FROM FAST OVERLOAD FRACTURE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DRILL BIT FRACTURED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL HIP MODULAR FLEX DRILL BIT HTW ZIMMER INC 61431861

    Patients

    Seq Age Sex Outcome Treatment
    1