BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIGLIANI/FLATOW STEM COLLAR COUNTERBORE

    MDR report key: 2860153 · Received November 21, 2012

    Report

    Report Number
    1822565-2012-02399
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 24, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RETURNED, THE COUNTER BORE GUIDE IS SEPARATED FROM THE HUMERAL COLLAR REAMER. THE TIP AT THE BASE OF THE HUMERAL COLLAR REAMER IS FRACTURED AND MISSING. NO INFORMATION OF THE FRACTURE TIP WAS GIVEN. BASED ON THE LOT NUMBER THE DEVICE HAS A POTENTIAL FIELD AGE OF APPROXIMATELY TWO YEARS AND SEVEN MONTHS. CAUSE CANNOT BE DEFINITIVELY DETERMINED. 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 REAMER WAS DIMENSIONALLY INSPECTED AND FOUND TO BE CONFORMING WHERE MEASURED WITH THE EXCEPTION TO THE PREVIOUSLY IDENTIFIED FRACTURE. THE HARDNESS OF THE REAMER WAS ALSO CHECKED AND IS WITHIN SPECIFICATIONS. INFORMATION ON WHAT REAMERS WHERE USED TO PREP THE HUMERAL CANAL WERE NOT PROVIDED. ALSO, WHAT STEM EXTENSION WAS USED ON THE REAMER IS UNKNOWN. THESE TWO DEVICES MAY HAVE CONTRIBUTED TO THE COUNTERBORE STICKING. IT WAS REPORTED THAT THE COUNTERBORE WAS REMOVED BY STRIKING IT WITH A MALLET. IT IS POSSIBLE THAT THE FRACTURED TIP WAS DUE TO THE STRIKES AND/OR LEVERING THE COUNTERBORE PERPENDICULAR TO THE AXIS OF THE HUMERUS WHILE REMOVING THE COUNTER BORE FROM THE HUMERAL CANAL, THEREBY CAUSING AN EXCESSIVE BENDING MOMENT ON THE THIN SECTION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE INSTRUMENT BECAME STUCK IN THE HUMERAL CANAL. A MALLET WAS USED TO REMOVE IT, BREAKING IT IN THE PROCESS. THERE WAS NO HARM DONE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIGLIANI/FLATOW STEM COLLAR COUNTERBORE HSD ZIMMER, INC. 61467315

    Patients

    Seq Age Sex Outcome Treatment
    1