BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURR,SLAP,4.5MM DSPL,DYO PWR /6

    MDR report key: 3523264 · Received December 17, 2013

    Report

    Report Number
    1219602-2013-00313
    Event Type
    Malfunction
    Date Received
    December 17, 2013
    Date of Event
    November 12, 2013
    Report Date
    November 22, 2013
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    HAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH ANTICIPATED, THE DEVICE HAS NOT YET BEEN RECEIVED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE RETURNED BURR, SLAP, 4.5MM DSPL, DYO PWR /6 WAS EVALUATED FOR THE REPORTED INCIDENT OF ¿BROKEN TIP¿ AND THE COMPLAINT WAS CONFIRMED. THE BURR WAS ANALYZED FOR DIMENSIONAL CONFORMANCE TO DESIGN SPECIFICATION AND WAS FOUND TO MEET ALL DESIGN TOLERANCES. THE OUTER SHEATH IS A 2 PIECE WELDMENT AND THE WELD PENETRATION WAS FOUND TO BE WITHIN PROCESS TOLERANCE. THE SHEATH, AT THE LOCATION WHERE IT DETACHED, WAS FOUND TO HAVE PHYSICAL DAMAGE TO THE OUTSIDE WALL, INDICATIVE OF USE OF THE TIP AS A LEVER. THE AREA OF THE WELD THAT DETACHED SHOWED DEFINITE DEFORMATION THAT WOULD INDICATE THAT THE SHEATH TUBE SAW EXCESSIVE LATERAL LOAD. NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE CAN BE ESTABLISHED. NO FURTHER INVESTIGATION IS REQUIRED. (B)(4).

    Description of Event or Problem · 1

    DURING A ARTHROSCOPY UTILIZING A BURR, SLAP,4.5MM DSPL,DYO PWR /6, IT WAS REPORTED THAT THE SHIELD OF THE BURR BROKE OFF. THE SMALL METAL PIECE IS STILL IN PATIENT'S JOINT. THE PATIENT HAD NO POSTOPERATIVE PAIN AND DECIDED NOT TO UNDERGO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659270 BURR,SLAP,4.5MM DSPL,DYO PWR /6 BURR,SLAP,4.5MM DSPL,DYO PWR /6 HAB MANSFIELD MANUFACTURING SITE 7209335 50615565

    Patients

    Seq Age Sex Outcome Treatment
    1