BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT DRIVER HOLDER ASSEMBLY

    MDR report key: 2140344 · Received June 16, 2011

    Report

    Report Number
    2027754-2011-00005
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 16, 2011
    Manufacturer
    OSTEOMED LP
    Product Code
    MDM
    PMA / PMN Number
    K102438
    Removal / Correction Number
    027754-06/16/2011-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE INVESTIGATION POINTS TO THE DIFFERENCE IN THE SHAPE OF THE THREAD FORM AT THE TIP AS POTENTIALLY THE MOST LIKELY ROOT CAUSE OF THE THREAD FAILURE OF THE DRIVER STEM THAT WAS OBSERVED IN THE FIELD. THE PROCEDURE WAS PERFORMED AS AN "OPEN" PROCEDURE WITHOUT A K-WIRE. THE IFU AND STG REFERENCE THE USE OF A K-WIRE DURING PLACEMENT. DECISION WAS MADE ON 06/07/2011 TO RECALL THE PRODUCT. (B)(4) WAS NOTIFIED ON (B)(4) 2011. FORMAL REPORT SUBMITTED ON (B)(4) 2011.

    Description of Event or Problem · 1

    AFTER DRILLING THE PILOT HOLE, THE SURGEON ATTACHED AN FF SCREW TO THE IMPLANT DRIVER HOLDER ASSEMBLY (800-1212) TO PLACE THE SCREW. WHILE PLACING THE SCREW INTO THE PREPARED HOLE AND BEGINNING TO THREAD INTO PLACE, THE DISTAL TIP OF THE IMPLANT HOLDER ASSEMBLY SHAFT BROKE OFF AND REMAINED CAPTURED WITHIN THE PROXIMAL HEAD OF THE FACET SCREW (800-1130). THE FACET SCREW HAD BARELY BEEN DRIVEN, SO IT WAS RETRIEVED WITHOUT DIFFICULTY USING A NEEDLE-NOSE GRASPER. THE THREADED IMPLANT DRIVER SHAFT WAS REMOVED FROM THE IMPLANT DRIVER ASSEMBLY AND WAS REPLACED WITH A SECOND SHAFT FROM THE KIT. A NEW 30MM FF SCREW WAS OPENED, LOADED ONTO THE IMPLANT DRIVER, AND IMPLANTED AT THE INTENDED LOCATION WITHOUT ISSUE. THE FIRST FF SCREW AND THE BROKEN THREADED IMPLANT DRIVER SHAFT WERE RETRIEVED AND RETURNED TO OSTEOMED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANT DRIVER HOLDER ASSEMBLY ORTHOPEDIC SURGICAL INSTRUMENT MDM OSTEOMED LP 800-1212 1038452

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR