BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6MM FEMORAL AIMER

    MDR report key: 3081634 · Received April 29, 2013

    Report

    Report Number
    0002936485-2013-00180
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 2, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    LXH
    PMA / PMN Number
    K951267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 TIP OF THE FEMORAL AIMER IS BROKEN OFF AT THE WELD. THERE WERE SIGNIFICANT SCRATCH MARKS PRESENT ON THE HANDLE OF THE AIMER AND THE ANODIZATION IS COMPLETELY STRIPPED OFF THE HANDLE. THE MOST LIKELY ROOT CAUSE FOR THIS FAILURE IS USER ERROR. THE AIMER MUST BE SIZED APPROPRIATELY WITH THE TIBIAL AND FEMORAL TUNNELS, SO THAT AFTER THE PIN HAS BEEN DRILLED INTO THE FEMORAL TUNNEL, THERE IS STILL ENOUGH ROOM IN THE TIBIAL TUNNEL TO RETRACT THE AIMER WITHOUT HITTING THE TIBIAL PLATEAU. FURTHERMORE, THE SURGEON CANNOT CHANGE THE KNEE FLEXION, AS THIS MAY FURTHER IMPEDE THE REMOVAL OF THE AIMER OUT OF THE TUNNEL. ADDITIONALLY, THE SCRATCHES ON THE HANDLE COULD INDICATE SOME USER MISUSE. THE HANDLE HAS BEEN IN THE FIELD FOR OVER FOUR YEARS, AND IT APPEARS THAT AGGRESSIVE CHEMICALS HAVE BEEN USED TO STERILIZE THE DEVICE; THIS COULD HAVE CONTRIBUTED TO THE FAILURE. 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 DURING A PROCEDURE, THE DEVICE BROKE AND REMAINED IN THE PATIENT'S KNEE. IT WAS LATER REMOVED COMPLETELY WITHOUT DELAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE DEVICE BROKE AND REMAINED IN THE PATIENT'S KNEE. IT WAS LATER REMOVED COMPLETELY WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183501 6MM FEMORAL AIMER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER ENDOSCOPY-SAN JOSE 45-068716

    Patients

    Seq Age Sex Outcome Treatment
    1