BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARALLEL SCREWDRIVER, SS

    MDR report key: 2553016 · Received April 30, 2012

    Report

    Report Number
    2027467-2012-00011
    Event Type
    Injury
    Date Received
    April 30, 2012
    Date of Event
    April 2, 2012
    Report Date
    April 2, 2012
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE SUSPECT DEVICE FOUND NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES. BOTH WERE PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. DIMENSIONAL AND FUNCTIONAL INSPECTION ALSO CONFIRMED THE RETURNED INSTRUMENTS MEET BOTH PRINT SPECIFICATION AND PERFORMANCE REQUIREMENTS. THE INVESTIGATION CONCLUDED THIS TYPE OF OCCURRENCE TO BE ATTRIBUTED TO MISALIGNMENT OF THE DRIVER DURING ENGAGEMENT TO THE SCREW. NON-AXIAL ALIGNMENT COULD RESULT IN INADEQUATE SURFACE CONTACT, RESULTING IN EXCESS LOADING ON A PARTICULAR SURFACE WHICH RESULTS IN STRIPPING. THE PARALLEL SCREWDRIVER FUNCTIONS AS INTENDED WHEN USED AS INSTRUCTED IN SURGICAL TECHNIQUE ((B)(4)).

    Additional Manufacturer Narrative · 1

    THE LOANER SET PROVIDED FOR THE SURGICAL CASE CONTAINED TWO PARALLEL SCREWDRIVERS WITH DIFFERENT MANUFACTURING LOT NUMBERS. BOTH RETURNED DEVICES ARE CURRENTLY BEING EVALUATED. UPON COMPLETION, A FOLLOW-UP REPORT WITH RESULTS OF THE INVESTIGATION WILL BE SUBMITTED. (B)(4) - PARALLEL SCREWDRIVER, SS, LOT# 6231602 MANUFACTURED 05/12/2011. LOT# 5773801 MANUFACTURED 02/02/2010.

    Description of Event or Problem · 1

    BOTH PARALLEL SCREWDRIVERS PROVIDED IN THE LOANER SET WERE COMPLETELY NON-FUNCTIONAL. THE DRIVERS STRIPPED EACH OF THE SIX IMPLANTED SCREWS DURING INSERTION AND WERE EXTREMELY DIFFICULT TO WORK WITH. THE SIXTH AND FINAL SCREW COULD NOT BE COMPLETELY ADVANCED /SEATED BENEATH THE LOCKING MECHANISM AS INTENDED. IT WAS LEFT PROUD APPROXIMATELY 1MM. THE CASE WAS DELAYED 30-40 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARALLEL SCREWDRIVER, SS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ALPHATEC SPINE INC 61736R 5773801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other