BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITT SAW-ATTACHM LONG W/T-HANDLE F/TRS

    MDR report key: 2842720 · Received November 21, 2012

    Report

    Report Number
    2520274-2012-03317
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 26, 2012
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AN INTERNAL INVESTIGATION WAS CONDUCTED. THERE ARE NO VISIBLE DAMAGES. DURING THE FUNCTION TEST, THE ATTACHMENT DID WORK AS REQUIRED AND IT WAS NOT POSSIBLE TO REPRODUCE THE COMPLAINED MALFUNCTION. THE EXACT CAUSE OF THIS OCCURRENCE IS NOT ABLE TO BE DETERMINED. POSSIBLE CAUSES ARE INSUFFICIENT TIGHTENING OF THE LOCKING SCREW OR THE USE OF A NON-COMPATIBLE SAW BLADE. THIS CREATES HIGHER VIBRATIONS, WHICH CAN LEAD TO A LOOSENING OF THE LOCKING SCREW. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A KNEE PROCEDURE SURGEON WAS USING THE SAW ATTACHMENT AND TRS HAND PIECE AND THE SCREW THAT HOLDS THE BLADE IN PLACE KEPT COMING LOOSE AFTER 75 MINUTES INTO THE PROCEDURE. THE SAW WAS USED APPROXIMATELY 5 OR 6 MINUTES IN THE PROCEDURE. IT WAS NOTED THIS HOSPITAL USES THE SAW IN DRILL MODE WHICH RUNS AT A HIGHER SPEED WHICH COULD CAUSE THIS PROBLEM. NO FURTHER INFORMATION AVAILABLE. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGITT SAW-ATTACHM LONG W/T-HANDLE F/TRS SAGITT SAW-ATTACHM LONG HWE SER.NO. 3272

    Patients

    Seq Age Sex Outcome Treatment
    1 SAGITTAL SAW ATTACHMENT, TRS HAND PIECE