BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL HIP MODULAR FLEX DRILL BIT

    MDR report key: 2020430 · Received February 8, 2011

    Report

    Report Number
    1822565-2011-00185
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    December 31, 2010
    Report Date
    January 12, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A 45MM AND A 30MM DRILL BIT WAS RETURNED FOR EVALUATION. AS RETURNED, BOTH DRILL BITS ARE FRACTURED APPROXIMATELY ONE INCH FROM THE TIP. THE 45MM BIT SHOWS SOME GOUGES ON THE FLUTE DIRECTLY DISTAL TO THE FRACTURE. DIMENSIONAL AND HARDNESS MEASUREMENTS WERE FOUND TO BE IN SPECIFICATION FOR BOTH DRILL BITS. IT IS UNK IF A DRILL GUIDE WAS USED WHEN DRILLING INTO THE BONE. THE "VERY HARD" BONE QUALITY OF THE PT WAS LIKELY A CONTRIBUTING FACTOR TO THESE FRACTURES. A DRILL BIT FRACTURE CAN ALSO 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 WEAR DUE TO USAGE WITH TIME; LOW SPEED/ HIGH TORQUE OF OPERATION. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THESE FRACTURES CANNOT BE DETERMINED WITH CERTAINTY. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE FLEXIBLE DRILL BIT(S) BROKE IN BONE DURING SURGERY. INSTRUMENTS WERE USED IN NORMAL FASHION IN WHAT THE SURGEON COMMENTED AS VERY HARD BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL HIP MODULAR FLEX DRILL BIT HTW ZIMMER INC 61574004

    Patients

    Seq Age Sex Outcome Treatment
    1 CATALOG #00879000704, LOT #61526812| TOTAL HIP INSTRUMENTATION MODULAR FLEX DRILL BIT