BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)

    MDR report key: 3107902 · Received May 10, 2013

    Report

    Report Number
    0002936485-2013-00211
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GFF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE WAS CONFIRMED. THE UNIT WAS VISUALLY INSPECTED FOR ANY WEAR MARKS OR ASSEMBLY ISSUES THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION. FURTHER INSPECTION DISCLOSED THAT ONE OF THE CUTTER TEETH HAD BROKEN OFF. PRONOUNCED WEAR MARKS COULD BE OBSERVED ON THE OUTER HOUSING TIP SURFACE. DENTS WERE OBSERVED ON THE HOUSING WINDOW EDGES, WHICH COINCIDE WITH THE CUTTER TOOTH THAT BROKE OFF. THE INNER CUTTER TIP WAS SLIGHTLY BENT, AS WELL AS SOME OF ITS TEETH, DUE TO THE DAMAGE RESULTING FROM HITTING THE OUTER HOUSING WINDOW. REVIEW OF THE DEVICE HISTORY RECORD OF THE SUBJECT PART AND LOT NUMBER DISCLOSED NO MANUFACTURING ISSUES THAT COULD BE RELATED TO THE REPORTED FAILURE CONDITION. PROBABLE ROOT CAUSE(S) FOR THE SUBJECT CONDITION CAN BE ASSOCIATED, BUT NOT LIMITED TO: COMPONENTS DO NOT FIT PROPERLY (ALIGNMENT/GAP BETWEEN CUTTER AND HOUSING ASSEMBLY), SHAVER BLADE COMES IN CONTACT WITH A METAL OBJECT (I.E. SCOPE) AND/OR EXCESSIVE FORCE/TORQUE APPLIED BY USER (BENDING/PRYING). IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAD METAL SHAVINGS DISINTEGRATE INSIDE THE PATIENT'S KNEE. FURTHER, A 20 MINUTE DELAY WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAD METAL SHAVINGS DISINTEGRATE INSIDE THE PATIENT'S KNEE. FURTHER, A 20 MINUTE DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209015 4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX) BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF STRYKER ENDOSCOPY-SAN JOSE 13024CE2

    Patients

    Seq Age Sex Outcome Treatment
    1