BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL RECIPROCATING SAW ATTACHMENT

    MDR report key: 4102279 · Received August 27, 2014

    Report

    Report Number
    8031000-2014-00304
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 14, 2014
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    HAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIVERSAL RECIPROCATING SAW ATTACHMENT PRODUCED METAL DEBRIS DURING SURGERY. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522703 UNIVERSAL RECIPROCATING SAW ATTACHMENT UNIVERSAL RECIPROCATING SAW ATTACHMENT HAB ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1