BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD CUTTER

    MDR report key: 3217643 · Received July 10, 2013

    Report

    Report Number
    8030965-2013-04163
    Event Type
    Malfunction
    Date Received
    July 10, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT (PD) EVALUATION WAS PERFORMED BY THE PD ENGINEER AND IT WAS REPORTED: THE ROD CUTTER WAS RECEIVED WITH DEFORMED CUTTING EDGES (2 RADIAL DEFORMATIONS-ONE ON EITHER SIDE). THERE ARE ALSO FRACTURES ON EITHER SIDE OF THE CUTTING BLADES. THE MISSING MATERIAL WAS NOT RETURNED WITH THE ROD CUTTERS. THE ROD CUTTER, PER THE PANGEA TECHNIQUE GUIDE, IS DESIGNED TO CUT RODS OF TITANIUM, TITANIUM ALLOY, AND STAINLESS STEEL OF DIAMETERS UP TO AND INCLUDING 6.0MM. THE SURGEON USED THIS ROD CUTTER TO CUT A COCR ROD WHICH IT IS NOT DESIGNED FOR. IN CONCLUSION, THE SURGEON USED THE 388.72 CUTTER TO CUT A COBALT CHROMIUM ROD WHICH THE DEVICE IS NOT DESIGNED FOR. THIS COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE. FURTHER, THE DEVICE HISTORY RECORDS (DHR) WAS REVIEWED AND THE REPORTS INDICATE, NO IRREGULARITIES WERE FOUND DURING THE DHR REVIEW. THE MATERIAL IS CORRESPONDING TO THE SPECIFICATIONS AND WAS SUPPLIED AT THE 18TH OF JANUARY 2012 WITH THE LOT'S 88660, 88661, 92835, 92836, 92837, 92838 AND 980716. THE HARDNESS WAS MEASURED AT THE TIME OF THE MANUFACTURING AT 47 HRC FOR THE BOLTS (420A), 45 HRC FOR MAIN BODY AND THE HINGE (BOTH 420A) AND 59 HRC FOR THE JAW SURFACES(1.4718). THEY WERE ALL FOUND TO BE GOOD. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS AT THE CUTTING EDGE THERE IS A LITTLE PIECE BROKEN OFF. OTHERWISE THERE ARE SLIGHT STRESS MARKS AT THE HANDLES, BUT THE DEVICE LOOKS TO BE IN GOOD CONDITION. IT IS APPROX. ONE AND A HALF YEAR OLD. COMPLAINT DESCRIPTION STATES THAT THE ROD CUTTER WAS USED TO CUT A COCR ROD. THE CUTTER IS SUITABLE FOR TITANIUM AND STAINLESS STEEL RODS ONLY, SO THE CUTTER WAS MISUSED BY THE OPERATOR.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    SYNTHES (B)(6) REPORTED DURING A MATRIX LOW BACK FUSION SURGERY ON (B)(6) 2013, THE ROD CUTTER TIP BROKE WHILE CUTTING A COCR ROD. NO PIECE WAS LEFT IN THE PATIENT. THE SURGEON WAS ABLE TO CUT THE ROD USING A DIFFERENT ROD CUTTER. REPORTEDLY THE SURGERY WAS NOT PROLONGED. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317323 ROD CUTTER HXZ SYNTHES GMBH T970320

    Patients

    Seq Age Sex Outcome Treatment
    1