BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD BENDER

    MDR report key: 6985723 · Received October 27, 2017

    Report

    Report Number
    3012447612-2017-00595
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    September 27, 2017
    Report Date
    March 27, 2018
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    HXW
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE RETURNED ROD BENDER WAS EVALUATED. THE DEVICE HAD DISASSEMBLED, AND VARIOUS SUBCOMPONENTS WERE DAMAGED AND FRACTURED. THE CAUSE OF FAILURE CAN MOST LIKELY BE ATTRIBUTED TO GRADUAL BACKING OUT OF THE HEX SCREW FROM USE OVER TIME. THE THREADS OF THE HEX SCREW ARE SHEARED NEAR THE TIP OF THE SHANK IMPLYING THAT THE SCREW WAS MOSTLY UNTHREADED BEFORE USE. ONCE PRESSURE WAS APPLIED TO THE BENDER DURING SURGERY, THE FORCE ON THE BENDER LIKELY EXPELLED THE SCREW THUS DAMAGING THE THREADS. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ROD BENDER DISASSEMBLED DURING SURGERY WHILE BENDING A ROD. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE ROD BENDER. THERE WERE NO PATIENT IMPACTS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763219 ROD BENDER BENDER HXW ZIMMER BIOMET SPINE INC. NA 013427

    Patients

    Seq Age Sex Outcome Treatment
    1