BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOUNTAINEER OCT MINIPOLYAXIAL SCREWDRIVER

    MDR report key: 2672523 · Received July 27, 2012

    Report

    Report Number
    1526439-2012-00159
    Event Type
    Malfunction
    Date Received
    July 27, 2012
    Date of Event
    June 22, 2012
    Report Date
    September 7, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY SYNTHES SPINE HAS REQUESTED RETURN OF THE DRIVER FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS NOT CONFIRMED AS THE RETURNED MINIPOLYAXIAL SCREWDRIVER WAS EXAMINED AND FOUND TO FUNCTION AS REQUIRED. THE MINIPOLYAXIAL SCREWDRIVER WAS DESIGNED TO BOTH INSERT AND BACK OUT THE POLYAXIAL SCREWS. A DIFFERENT SCREWDRIVER, THE SUMMIT STYLE MINI-POLYAXIAL SCREWDRIVER, PRODUCT CODE 2883-04-200, IS INTENDED TO BE USED TO HOLD SCREWS STRAIGHT.AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT AFTER INITIAL SPINAL SURGERY WAS PERFORMED ON (B)(6) 2012, THE PATIENT EXPERIENCED NON-DEVICE RELATED PAIN. SURGERY WAS PERFORMED AND PREVIOUSLY IMPLANTED SCREWS WERE REMOVED AND REPLACED. DURING SCREW INSERTION, THE SURGEON NOTICED THAT THE DRIVER AND SCREW DID NOT MAINTAIN ALIGNMENT DURING INSERTION. ANOTHER SCREW WAS TRIED WITH THE DRIVER AND THE CONNECTION BETWEEN THE TIP OF THE DRIVER AND THE SCREW HEAD WAS FOUND TO BE LOOSE. THE SCREW WAS EVENTUALLY PLACED IN BONE WITHOUT INJURY AND SURGERY WAS COMPLETED. HOWEVER, THE PROCEDURE WAS EXTENDED BY THIRTY MINUTES AS A RESULT OF THE DIFFICULTY. THE SURGEON BELIEVES THE DIFFICULTY WAS RELATED TO THE GRIPPING FUNCTION OF THE SCREWDRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOUNTAINEER OCT MINIPOLYAXIAL SCREWDRIVER ORTHOPEDIC, MANUAL, SURGICAL INSTRUMENT LXH DEPUY RAYNHAM X0609

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR MOUNTAINEER SCREW, (B)(4)| MOUNTAINEER MINIPOLY DRIVER, (B)(4)