BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARRAY 5.5 TABLE TOP ROD CUTTER

    MDR report key: 5776368 · Received July 7, 2016

    Report

    Report Number
    3004485144-2016-00142
    Event Type
    Malfunction
    Date Received
    July 7, 2016
    Date of Event
    June 7, 2016
    Report Date
    March 3, 2017
    Manufacturer
    BIOMET SPINE - BROOMFIELD
    Product Code
    HXW
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE IFU (INSTRUCTIONS FOR USE) STATES "AVOID NOTCHING OR SCRATCHING OF THE DEVICE, WHICH COULD INCREASE INTERNAL STRESSES AND LEAD TO EARLY BREAKAGE." AS THE ROD WAS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION, IT IS UNKNOWN IF THE ISSUE CAUSED ANY STRESS FRACTURES. BASED ON THE INFORMATION AVAILABLE THE ROOT CAUSE IS UNABLE TO BE CONCLUSIVELY DETERMINED, HOWEVER THE MOST LIKELY CAUSE OF THE EVENT IS THE DEVICE WAS NOT PROPERLY MAINTAINED. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: COMMON DEVICE NAME, (B)(4),: 510(K) NUMBER, AND METHOD, RESULTS, AND CONCLUSION CODES. THE DEVICE PRODUCT CODE SHOULD BE FZT. CORRECTION/CLARIFICATION: THERE IS NO ROUTINE OR PREVENTIVE MAINTENANCE ASSOCIATED WITH THIS DEVICE. IF THE DEVICE BECOMES DULL FROM USE, IT IS REMOVED FROM USE AND REPLACED. THE PRODUCT WAS NOT RETURNED, SO NO EVALUATION COULD BE PERFORMED AND NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT IS REPORTED THE ROD CUTTER DID NOT CUT SMOOTHLY DURING A PROCEDURE. IT SEEMS TO BE WORN AND NEEDS TO BE SHARPENED AS IT IS LEAVING A ROUGH EDGE ON THE ROD. NO SURGICAL DELAY OR PATIENT INJURY WAS REPORTED AND THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430646 ARRAY 5.5 TABLE TOP ROD CUTTER CUTTER, SURGICAL HXW BIOMET SPINE - BROOMFIELD N/A 613268

    Patients

    Seq Age Sex Outcome Treatment
    1