BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M/DN INTRAMEDULLARY DISTAL DRILL, PILOT TIP

    MDR report key: 2091556 · Received March 23, 2011

    Report

    Report Number
    1822565-2011-00717
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO RECEIVED VIA MEDWATCH (B)(4). EVAL SUMMARY: IT IS UNCLEAR IN WHAT MANNER THE PRODUCT WAS USED. IT IS UNK WHAT TYPE OF LOADING THE DRILL WAS SUBJECTED TO DURING SURGERY (I.E. BENDING MOMENT LOADS). NO OTHER COMPLAINTS FOR THIS DRILL HAVE BEEN REPORTED. EVAL: 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 INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS DRILLING A HOLE FOR DISTAL SCREW PLACEMENT IN THE PT'S LEG DURING REPAIR OF A FEMUR FRACTURE. THE 5.0 SHORT DRILL BIT BROKE OFF IN THE BONE. THE SURGEON ATTEMPTED TO REMOVE THE BROKEN DRILL BIT, BUT THE BIT "STUCK" IN THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M/DN INTRAMEDULLARY DISTAL DRILL, PILOT TIP HTW ZIMMER, INC. 61228076

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR