BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURAL-KNEE HEX HEAD SCREWDRIVER BIT

    MDR report key: 2062895 · Received March 18, 2011

    Report

    Report Number
    1822565-2011-00659
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    January 25, 2010
    Report Date
    February 11, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A LIKELY CAUSE FOR THIS EVENT IS THE RESULT OF APPLYING A LOAD TO THE DRIVER AT AN OFF-AXIS ANGLE AND/OR APPLYING FORCE PERPENDICULAR TO THE DRIVER'S SHAFT CREATING A BENDING MOMENT THAT CAN CAUSE FRACTURE. THE INSTRUMENT HAD A POTENTIAL FIELD AGE OF 26 MONTHS AT THE TIME OF THIS INCIDENT. THE HARDNESS OF THE MATERIAL WAS FOUND TO BE WITHIN PRINT SPECIFICATION. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE ASCERTAINED AT THIS TIME. 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. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE HEX TIP FRACTURED OFF THE INSTRUMENT WHILE INSERTING A SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE HEX HEAD SCREWDRIVER BIT KNEE INSTRUMENT HXX ZIMMER, INC. 60856646

    Patients

    Seq Age Sex Outcome Treatment
    1