BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX

    MDR report key: 3122175 · Received May 21, 2013

    Report

    Report Number
    1030489-2013-01803
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    March 12, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUALLY CONFIRMED THE INSTRUMENT HANDLE SCREW IS MISSING. OPTICAL INSPECTION OF THE SCREW HOLE AND THE SURROUNDING SURFACE DID NOT REVEAL WITNESS MARKS OR OTHER INDICATIONS REGARDING THE MECHANISM OF FAILURE. THIS INSTRUMENT IS DESIGNED TO BE DISASSEMBLED FOR CLEANING PURPOSES. THE MANUFACTURING LOT CODE SUGGESTS THAT THE INSTRUMENT HAS BEEN IN USE FOR SOME TIME, MAKING IT UNLIKELY THAT THIS IS A MANUFACTURING ISSUE. ADDITIONALLY, THE INFERIOR SHAFT IS BROKEN AT THE CENTERLINE OF THE LOWER PIVOT PIN HOLE. OPTICAL EXAMINATION IDENTIFIED A FAIRLY BRITTLE FRACTURE, WITH NO INDICATION OF FATIGUE. THE LOCATION AND AMOUNT OF FORCE REQUIRED IN ORDER INDUCE FRACTURE OF THE SHAFT IS CONSISTENT WITH OVERLOAD. ALSO THE INSTRUMENT SHAFT IS BENT. REGARDING THE MISSING SCREW NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR THE PROCESSING OF THE INSTRUMENT. UNABLE TO DEFINITIVELY DETERMINE SPECIFIC ROOT CAUSE OF THE FOREGOING EVENT FROM THE AVAILABLE INFORMATION. REGARDING THE SHAFT FRACTURE, THE ABOVE OBSERVATIONS ARE CONSISTENT WITH OVERLOAD OF THE INSTRUMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOTTOM JAW BROKE OFF OF THE DOWNBITING PITUITARY AND THE SCREW THAT HOLDS THE HANDLE TOGETHER ALSO FELL OFF DURING AN UNSPECIFIED SPINAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223683 METRX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA GZ04F065

    Patients

    Seq Age Sex Outcome Treatment
    1