BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING BACKBITER, PED. 1/EA

    MDR report key: 3836060 · Received May 28, 2014

    Report

    Report Number
    1045254-2014-00123
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    KAE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED. AN EVALUATION/ANALYSIS OF THE DEVICES CANNOT BE PERFORMED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RECEIVED IN AN UNLABELED PADDED FOAM MEDTRONIC INSTRUMENT BOX. THE SHAFT OF THE INSTRUMENT WAS FOUND BENT WHICH WAS INDICATIVE OF AGGRESSIVE USE OF THE INSTRUMENT BY THE CUSTOMER. THE INSTRUMENT WAS FOUND FRACTURED NEAR THE TIP WHICH CAUSED THE BACKBITER TO NOT FUNCTION UPON ACTUATION OF HANDLE. UPON OBSERVING THE FRACTURED LOCATION, THERE WAS SOME AMOUNT OF CORROSION OBSERVED WHICH MAY HAVE LIKELY DETERIORATED THE MATERIAL AND WHEN COMPOUNDED WITH EXCESSIVE FORCE BY THE CUSTOMER DURING USE, THE INSTRUMENT FRACTURED AT THIS LOCATION. THERE WAS NO EVIDENCE OF IMPROPER MANUFACTURING, THEREFORE MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE. BASED ON THE ABOVE OBSERVATIONS; THE MOST LIKELY UNDERLYING CAUSE IS CONSISTENT WITH MISHANDLING, BASED ON THE BENT SHAFT WHICH INDICATED AGGRESSIVE USE OF THE INSTRUMENT AND THE FRACTURED POINT. (B)(4)

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT NEAR THE TIP OF THE INSTRUMENT, A PIECE IS SNAPPED OFF. THE INSTRUMENT WAS FOUND ON AN INSTRUMENT TRAY DURING SURGERY ON (B)(6) 2014. THERE WAS NO INJURY OR IMPACT TO THE PATIENT REPORTED. THE CUSTOMER WAS NOT AWARE OF ANY FRAGMENT OF THE INSTRUMENT HAVING TO BE REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313501 ROTATING BACKBITER, PED. 1/EA FORCEPS, ENT KAE MEDTRONIC XOMED INC. 3712013

    Patients

    Seq Age Sex Outcome Treatment
    1