BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL PUNCH TOWER ASSEMBLY

    MDR report key: 2941878 · Received February 4, 2013

    Report

    Report Number
    0002249697-2013-00550
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DIFFICULTY REMOVING TIBIAL PUNCHES FROM A SCORPIO MIS TIBIAL PUNCH TOWER WAS REPORTED. THE EVENT WAS CONFIRMED. THE RETURNED DEVICE WAS IN USED CONDITION. THE FRONT FACE OF THE INSTRUMENT IS SIGNIFICANTLY MARKED FROM IMPACTION, ESPECIALLY AROUND THE SLOT THROUGH WHICH THE TIBIAL PUNCH SHAFT IS PASSED DURING ASSEMBLY IN SURGERY. THIS DAMAGE HAS DEFORMED THE SLOT WHICH PREVENTED TWO SAMPLE TIBIAL PUNCHES FROM BEING EASILY ASSEMBLED WITH THE COMPLAINT DEVICE. THE NOTED DAMAGE IS NOT CONSISTENT WITH NORMAL USE OF THE DEVICE. NO FURTHER INFORMATION WAS REQUESTED AS THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO PATIENT FACTORS. DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW FOUND NO OTHER EVENTS HAVE BEEN REPORTED FOR THE MANUFACTURING LOT. THE INVESTIGATION CONCLUDED THE DISASSEMBLY DIFFICULTIES WERE RELATED TO DEFORMATION OF THE DEVICE FROM IMPACTION DAMAGE. THE LOCATION OF THE IMPACTION IS NOT CONSISTENT WITH NORMAL USE OF THE DEVICE. THE ROOT CAUSE IS CONCLUDED TO BE USER MISUSE.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS DIFFICULT TO REMOVE THE KEEL PUNCH FROM THE UPPER SPACE OF THE KEEL PUNCH TOWER SMOOTHLY. THE SURGEON SAID THE UPPER SPACE OF THE AFFECTED TOWER WAS MORE NARROW THAN THE SAME PRODUCTS WHICH HE HAS USED USUALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS DIFFICULT TO REMOVE THE KEEL PUNCH FROM THE UPPER SPACE OF THE KEEL PUNCH TOWER SMOOTHLY. THE SURGEON SAID THE UPPER SPACE OF THE AFFECTED TOWER WAS MORE NARROW THAN THE SAME PRODUCTS WHICH HE HAS USED USUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46372 TIBIAL PUNCH TOWER ASSEMBLY INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH MMYV02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other