BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM TOMCAT CUTTER, FORMULA (5BX)

    MDR report key: 3680420 · Received March 14, 2014

    Report

    Report Number
    0002936485-2014-00125
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    February 20, 2014
    Report Date
    February 20, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GFF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FAILURE CONDITION (TIP BREAKAGE) IS CONSIDERED CONFIRMED UPON VISUAL INSPECTION OF THE UNIT RECEIVED. EVEN THOUGH THE TIP DID NOT COMPLETE BREAK WE EVALUATED CONSERVATIVELY THE WORST CASE BREAKAGE CONDITION. MOST PROBABLE ROOT CAUSE(S) FOR THE REPORTED FAILURE MODE CAN BE ASSOCIATED, BUT NOT LIMITED TO: EXCESSIVE FORCE APPLIED BY USER; INADEQUATE SIZE SELECTED FOR THE APPLICATION; INADEQUATE WINDOW PROFILE. A UNIQUE ROOT CAUSE CANNOT BE IDENTIFIED FOR THIS PARTICULAR EVENT SINCE NONE OF THE ABOVE COULD BE RULED OUT. THUS THE ROOT CAUSE WILL REMAIN AS MULTI-FACTORIAL. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACL CASE WHILE TAKING SOFT TISSUE AROUND THE TUNNEL SITE THE OUTER SHAFT OF THE BLADE CRACKED. THE DOCTOR TOOK THE BLADE OUT OF THE KNEE AND REQUESTED A NEW ONE. NO PART OF THE SHAVER FELL OFF IN THE KNEE IT ALL CAME OUT WITH THE BLADE AND A NEW BLADE WAS PUT USED TO CONTINUE THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ACL CASE WHILE TAKING SOFT TISSUE AROUND THE TUNNEL SITE THE OUTER SHAFT OF THE BLADE CRACKED. THE DOCTOR TOOK THE BLADE OUT OF THE KNEE AND REQUESTED A NEW ONE. NO PART OF THE SHAVER FELL OFF IN THE KNEE IT ALL CAME OUT WITH THE BLADE AND A NEW BLADE WAS PUT USED TO CONTINUE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154676 4.0MM TOMCAT CUTTER, FORMULA (5BX) BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF STRYKER ENDOSCOPY-SAN JOSE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1