BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD CUTTER

    MDR report key: 3628522 · Received February 14, 2014

    Report

    Report Number
    8030965-2014-00292
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 31, 2014
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A 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 MATERIALS WHICH WERE DELIVERED AS LOT #000104046/ #000104046/ #000104050 ARE CORRESPONDING TO THE SPECIFICATIONS. THE HARDNESS WAS MEASURED AT THE TIME OF THE MANUFACTURING BETWEEN 46-47 HRC FOR 1.4021 AND 54 HRC FOR 1.4718 AND WAS FOUND TO BE GOOD. NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS COMPLETED: BOTH JAWS ARE BADLY DAMAGED. A PIECE OF ONE JAW HAS BROKEN OFF. THE CUTTER CORRESPONDS TO THE PROCESSES AT THE TIME OF MANUFACTURE; THE DRAWING IS TO BE CHANGED TO ADD THE MATERIAL USED FOR THE CUTTING EDGES. THE DAMAGE IS CONSISTENT TO THAT OF WHAT HAPPENS IF THE CUTTER IS USED TO CUT COCR RODS. SEE TEST REPORT # LFD NR. 26 OR CAPA DETERMINATION # (B)(4). A FUNCTION TEST WAS CARRIED OUT ON THE CUTTER WITH A Ø6MM TITANIUM ROD 498.290 WITH LOT # 7679617. THE CUTTER SHEARED THE ROD WITHOUT CAUSING FURTHER DAMAGE TO THE CUTTER. IT IS LIKELY TOO MUCH FORCE WAS APPLIED TO THE JAWS CAUSING THEM TO BREAK. THE CUTTER IS APPROXIMATELY ONE AND HALF YEARS OLD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PAIR OF CUTTERS BROKE DURING SURGERY. THE SURGEON WAS PERFORMING A THORACOLUMBAR REVISION SURGERY AT THE TIME THE CUTTERS BROKE. THE REVISION SURGERY DID NOT INVOLVE A SYNTHES DEVICE (BESIDES THE CUTTERS). NO PATIENT INFORMATION IS AVAILABLE. THE SURGEON WAS TRYING TO CUT THE ROD IN SITU, FOR A 5.5MM TITANIUM SYSTEM THEY HAD IN. THE CUTTERS BROKE AT THE TIP. THIS WAS THE FIRST TIME CUTTERS WERE BEING USED IN SURGERY. THE SURGEON WAS ABLE TO EASILY REMOVE THE BROKEN FRAGMENTS FROM THE PATIENT/FIELD EASILY WITHOUT ADDITIONAL MEDICAL INTERVENTION. THE SURGEON THEN USED THE SECOND CUTTER TO SUCCESSFULLY COMPLETE THE PROCEDURE; HOWEVER IT WAS NOTED THIS CUTTER NOW HAS AN INDENTATION IN THE JAWS OF THE CUTTER. THERE WAS A LESS THAN TEN MINUTE DELAY IN THE PROCEDURE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97564 ROD CUTTER HXZ SYNTHES GMBH T985174

    Patients

    Seq Age Sex Outcome Treatment
    1