BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2132889 · Received June 17, 2011

    Report

    Report Number
    1056128-2011-00052
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 24, 2011
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT THE DEVICE HAD NOT BEEN RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS AND AN INVESTIGATION HAD NOT BEEN CONDUCTED. AT THIS POINT IT IS UNKNOWN WHAT THE PART NUMBER OF THE DEVICE IS OR ANY OTHER DEVICE INFORMATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    AFTER THE INITIAL MDR WAS FILED, COMMUNICATION WITH THE USER FACILITY CONFIRMED THE BURR WAS NOT A REPROCESSED DEVICE. SO THE DEVICE WAS NOT RECEIVED BY THE FACILITY FROM (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BUR BROKE OFF FROM THE DRILL AND HIT A SCRUB TECHNICIAN ON THE SHOULDER DURING PREPARATION FOR A PROCEDURE. THE SHAFT OF THE BUR REMAINED IN THE DRILL. NO MEDICAL TREATMENT WAS REQUIRED AND THERE WAS NO INJURY REPORTED FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A HRX HRX STRYKER SUSTAINABILITY SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1