BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MG II TOTAL KNEE SYSTEM BONE SCREW DRILL

    MDR report key: 2102849 · Received April 12, 2011

    Report

    Report Number
    1822565-2011-01166
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 15, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIT AND BLOCK HAVE A POTENTIAL FIELD AGE OF OVER 3 YEARS AND APPROX 2.5 YEARS RESPECTIVELY AND HAVE BEEN USED AN UNK NUMBER OF TIMES DURING THAT PERIOD. AS RETURNED, BOTH THE BLOCK AND THE BIT EXHIBIT SUBSTANTIAL WEAR, INDICATIVE OF EXTENSIVE USE IN THE FIELD. THE FLUTED PORTION OF THE RETURNED BIT IS VERY DULL AND CIRCUMFERENTIAL SCARRING CAN BE SEEN ON THE SHAFT IN THE AREA OF THE FRACTURE, INDICATING INTERFERENCE WITH THE BIT. IT IS LIKELY THAT DAMAGE TO BOTH THE BIT AND BLOCK (ACCRUED THROUGH PREVIOUS USE) CREATED INTERFERENCE BETWEEN THE DEVICES, EVENTUALLY LEADING TO SEIZURE AND FRACTURE. WITHOUT FURTHER INFO ABOUT THE USAGE HISTORY OF THE DEVICES, HOWEVER, THE EXACT CAUSE OF THIS EVENT CANNOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. MATERIAL HARDNESS OF BOTH ITEMS WAS MEASURED AND FOUND TO BE WITHIN PRINT SPECIFICATION LIMITS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DRILL BECAME COLD WELDED TO THE BLOCK AND BROKE IN HALF. SURGERY WAS COMPLETED WITH A 2.5 DRILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MG II TOTAL KNEE SYSTEM BONE SCREW DRILL HTW ZIMMER, INC. 60905841

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS| FEMORAL SAW GUIDE: CATALOG #00541304114| MULTI-REFERENCE 4-IN-1 FEMORAL INSTRUMENTATION| LOT #61054262