BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX

    MDR report key: 3915051 · Received July 6, 2014

    Report

    Report Number
    1030489-2014-03014
    Event Type
    Malfunction
    Date Received
    July 6, 2014
    Date of Event
    June 6, 2014
    Report Date
    July 16, 2014
    Manufacturer
    MSD BARTLETT MFG
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A PORTION OF THE SUPERIOR SHAFT TIP IS BROKEN OFF AND NOT RETURNED AT THE CENTERLINE OF THE PIVOT PIN FORWARD. THE LOCATION, AND AMOUNT OF FORCE REQUIRED IN ORDER TO INDUCE FRACTURE 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 DURING AN UNSPECIFIED SPINAL SURGERY THE SCREW CAME OUT OF THE HANDLE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393044 METRX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MSD BARTLETT MFG NA GZ05G054

    Patients

    Seq Age Sex Outcome Treatment
    1