BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX

    MDR report key: 3061902 · Received April 16, 2013

    Report

    Report Number
    1030489-2013-01071
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MSD BARTLETT MFG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE UPPER PIVOT PIN IS MISSING, AND THE LOWER STATIC JAW TIP IS CRACKED AT THE CENTER OF THE LOWER PIVOT PIN. OPTICAL EXAMINATION OF THE UPPER PIVOT PIN HOLE IDENTIFIED MATERIAL DEFORMATION AROUND THE HOLE, CONSISTENT WITH OVERLOAD. THE LOCATION, AND AMOUNT OF FORCE REQUIRED IN ORDER TO INDUCE DEFORMATION AND CRACKING OF THE SHAFT IS CONSISTENT WITH OVERLOAD.

    Additional Manufacturer Narrative · 1

    (B)(4): THE INSTRUMENT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UPBITING PITUITARY WAS BROKEN AT THE JAWS, AND A SCREW WAS MISSING DURING AN UNKNOWN SPINE SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163964 METRX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MSD BARTLETT MFG NA GZ06M074

    Patients

    Seq Age Sex Outcome Treatment
    1