BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 2975363 · Received February 7, 2013

    Report

    Report Number
    1719045-2013-10059
    Event Type
    Malfunction
    Date Received
    February 7, 2013
    Date of Event
    March 11, 2011
    Report Date
    March 14, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KTT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE (S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD'L INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DHR REVIEW PERFORMED: A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MFG REVEALED NO COMPLAINT RELATED ISSUES. VISUAL INSPECTION OF THE SCREW REVEALED THE THREAD HAS BEEN RUSHED ON THE TIP OF THE PART. UNABLE TO ACCURATELY VERIFY THE THREAD WITH THE THREAD RING GAGE. IT WAS ALSO NOTED THE PART HAD INDICATIONS OF SCUFF MARKS SCRATCHES AND NICKS. THE CAP ALSO HAS SIGNS OF DAMAGE TO THE BACK SURFACE AND NICKS ON THE KNURLED SURFACE. CAUSE OF DAMAGE IS UNK. D4: REPORTED LOT NUMBER IS INVALID. LOT NUMBER USED FOR DHR REVIEW IS 6172520.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY, THE BLADE GUIDE SLEEVE AND WIRE GUIDE JAMMED TOGETHER. THE DEVICES ARE STILL JAMMED AND CANNOT BE REMOVED FROM EACH OTHER. HELICAL BLADE COUPLING SCREW WAS NOT ABLE TO THREAD INTO THE HELICAL BLADE DUE TO A DISRUPTION TO THE THREADS. ADD'L DEVICES WERE TAKEN FROM ANOTHER INSTRUMENT TRAY. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53112 HELICAL BLADE COUPLING SCREW KTT SYNTHES MONUMENT IS10223

    Patients

    Seq Age Sex Outcome Treatment
    1