BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO PERFORATOR CHUCK

    MDR report key: 2243675 · Received July 28, 2011

    Report

    Report Number
    1811755-2011-02694
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 1, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBB
    PMA / PMN Number
    K041754
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE U.S MFR FOR EVAL. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE PRODUCT IS RETURNED, AND IF THE INVESTIGATION RESULTS REQUIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRANIOTOMY, THE PERFORATOR CHUCK HEATED UP. BACKUP EQUIPMENT WAS USED TO COMPLETED THE PROCEDURE. NO PT OR USER INJURY WAS REPORTED, AS A RESULT OF THE CHUCK. IT WAS ALSO REPORTED THAT DURING THE SAME PROCEDURE, THE DURA MATER WAS TORN, WHICH RESULTED IN A CSF LEAK. THE LEAK STOPPED ON IT'S OWN AND THE SURGEON WAS ABLE TO REPAIR THE TEAR USING A DURA PATCH. IT WAS REPORTED THAT A CODMAN (NON-STRYKER) PERFORATOR BIT WAS BEING USED WITH THE STRYKER PERFORATOR CHUCK. THE CODMAN PERFORATOR BIT WAS THE DEVICE TO TEAR THE DURA MATER. THIS INCIDENT DID NOT IMPACT THE PT'S SURGICAL OUTCOME, RECOVERY, OR LENGTH OF HOSPITAL STAY. NO LONG-TERM HEALTH IMPLICATIONS FOR THE PT ARE EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO PERFORATOR CHUCK HBB STRYKER INSTRUMENTS KALAMAZOO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK