BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN SITU BENDER-LEFT FOR 5.5MM RODS

    MDR report key: 5197393 · Received November 3, 2015

    Report

    Report Number
    9680938-2015-10103
    Event Type
    Malfunction
    Date Received
    November 3, 2015
    Date of Event
    October 16, 2015
    Report Date
    October 16, 2015
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HXW
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION SUMMARY ¿THE RETURNED INSTRUMENT ((B)(4) LOT T990684 MFG 5/2013) WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS ONE OF THE JAWS WAS FOUND TO BE BROKEN OFF AND WAS NOT RETURNED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED HOWEVER THE FAILURE MODE IS CONSISTENT WITH THE ROD NOT FULLY SEATING IN THE BENDER DURING USE, RESULTING IN AN INCREASED BENDING MOMENT AT THE TIP. THE IN SITU BENDER ((B)(4)) IS A COMPONENT OF THE MATRIX DEFORMITY INSTRUMENT AND 5.5MM TITANIUM ROD SET WHICH IS UTILIZED FOR POSTERIOR PEDICLE SCREW, HOOK AND ROD FIXATION. THE IN SITU BENDER IS ONE OF THREE METHODS OF ROD CONTOURING PRIOR TO INSERTION AND REDUCTION. THE RETURNED INSTRUMENT (B)(4) LOT T990684) WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS ONE OF THE JAWS WAS FOUND TO BE BROKEN OFF AND WAS NOT RETURNED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED HOWEVER THE FAILURE MODE IS CONSISTENT WITH THE ROD NOT FULLY SEATING IN THE BENDER DURING USE, RESULTING IN AN INCREASED BENDING MOMENT AT THE TIP. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBERS AND IN EACH INSTANCE NO MRRS, NCRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOTS NUMBERS WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE HARDNESS WAS MEASURED AT THE TIME OF MANUFACTURING AT 53.9 HRC AND WAS FOUND TO BE GOOD. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. MANUFACTURING DATE: 07MAY2013. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RAW MATERIAL WAS CORRESPONDING TO THE SPECIFICATIONS. THE HARDNESS WAS MEASURED AT THE TIME OF THE MANUFACTURING AND WAS FOUND TO BE GOOD. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT IS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE A SMALLER, NON-SYNTHES HARDWARE AND IMPLANT SYNTHES HARDWARE FROM T3-ILIUM ON (B)(6) 2015. DURING THE PROCEDURE WHILE IMPLANTING THE SYNTHES HARDWARE, SURGEON WAS ATTEMPTING TO CORONALLY BEND THE COBALT CHROMIUM ROD WHEN THE TIP OF THE BENDER FORK BROKE OFF. ALL PIECES WERE RETRIEVED, NO FRAGMENTS REMAIN IN PATIENT. ANOTHER DEVICE WAS READILY AVAILABLE. PROCEDURE WAS DELAYED APPROXIMATELY THREE (3) MINUTES AND COMPLETED SUCCESSFULLY WITH NO FURTHER HARM TO PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728403 IN SITU BENDER-LEFT FOR 5.5MM RODS BENDER HXW SYNTHES TUTTLINGEN T990684

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR