BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN SITU BENDER-RIGHT FOR 5.5MM RODS

    MDR report key: 5820585 · Received July 25, 2016

    Report

    Report Number
    9680938-2016-10109
    Event Type
    Malfunction
    Date Received
    July 25, 2016
    Date of Event
    July 11, 2016
    Report Date
    July 11, 2016
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HXW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT WEIGHT IS NOT AVAILABLE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. MANUFACTURING DATE: MARCH 14, 2012. REVIEW OF THE DEVICE HISTORY RECORD OF (B)(4) SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. A REVIEW OF INSPECTION RECORDS AND CERTIFICATIONS, CONFIRM THAT THE, MATERIAL, COMPONENTS AND FINAL PRODUCT MET INSPECTION RECORDS, CERTIFICATION. ALL (B)(4) PARTS OF THE LOT WERE CHECKED 100% FOR CTQ FEATURES AND FOR FUNCTION AT THE FINAL INSPECTION ON 06-FEB-2012. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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: AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: A ROD BENDER (03.632.038 LOT T973702) BROKE WHILE ATTEMPTING TO BEND A COBALT CHROMIUM ROD; FRAGMENT RETRIEVED. THE PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED WITHOUT PATIENT HARM OR SURGICAL DELAY. THE RETURNED INSTRUMENT WAS EXAMINED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE JAW ON THE STRAIGHT END OF THE INSTRUMENT WAS FOUND TO BE BROKEN; FRAGMENT 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. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. 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

    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 WAS REPORTED THAT ON JULY 11, 2016, THE PATIENT UNDERWENT A REVISION SURGERY (HARDWARE REMOVED WAS BY AN UNKNOWN VENDOR) AND WHILE THE SURGEON WAS LAYING THE COBALT CHROMIUM ROD AND USING THE IN-SITU BENDER TO BEND THE ROD INTRA-OPERATIVELY, THE TIP OF THE BENDER BROKE. THE FRAGMENT TIP WAS EASILY RETRIEVED. NO HARM TO THE PATIENT WAS REPORTED AND THERE WAS NO SURGICAL DELAY. A BACK-UP IN-SITU BENDER WAS AVAILABLE FOR THE SURGEON TO SUCCESSFULLY COMPLETE THE PROCEDURE. CONCOMITANT DEVICES REPORTED: ROD (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), HARDWARE REMOVED/UNKNOWN VENDOR (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473258 IN SITU BENDER-RIGHT FOR 5.5MM RODS BENDER HXW SYNTHES TUTTLINGEN T973702

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR