BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVICE REP, MDU,ULTRALIGHT

    MDR report key: 4928905 · Received July 21, 2015

    Report

    Report Number
    1643264-2015-00041
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    January 18, 2013
    Report Date
    July 21, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLADE SHEDDING IS THE LOSS OR EMISSION OF SMALL FLAKES OR PARTICLES DUE TO CONTACT OF MECHANICAL SURFACES DURING BLADE ROTATION. TYPICALLY, THIS SHED MATERIAL MAY BE RESECTED OR SUCTIONED AWAY FROM THE TISSUE DURING THE SURGICAL PROCEDURE. HOWEVER, FAILURE TO RETRIEVE ALL DEBRIS MAY NECESSITATE MEDICAL OR SURGICAL INTERVENTION. AS A RESULT, THIS EVENT IS CONSIDERED REPORTABLE PURSUANT TO 21 C.F.R. §803. INVESTIGATION OF THE RETURNED PRODUCT PASSED FUNCTIONAL TESTING. NO METAL SHAVINGS WERE FOUND IN OR ON UNIT. BLADE USED WITH UNIT WAS NOT RETURNED FOR ANALYSIS. DEFECTIVE BLADE COULD HAVE BEEN RESPONSIBLE FOR METAL SHAVINGS. NO PROBLEM FOUND. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    DURING A ROTATOR CUFF PROCEDURE USING A SERVICE REP, MDU, ULTRALIGHT DEVICE DURING USE THE SHAVER IN THE JOINT MR (B)(6) NOTICED METAL SHEARS IN THE JOINT FROM THE SHAVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473291 SERVICE REP, MDU,ULTRALIGHT SAW, POWERED, AND ACCESSORIES HAB SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1