BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK/SCREW HOLDER WITH 4.0MM HEX

    MDR report key: 3984381 · Received August 6, 2014

    Report

    Report Number
    2530088-2014-10209
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: PER THE TECHNIQUE GUIDE, THE HOOK/SCREW HOLDER WITH 4.0MM HEX (388.612) IS A COMPONENT OF THE UNIVERSAL SPINE SYSTEM (USS) INSTRUMENT SET (105.127) AND THE SMALL STATURE USS INSTRUMENT SET (105.123), WHICH ARE INTENDED TO BE USED WITH THE USS AND SMALL STATURE USS SYSTEMS. BOTH USS SYSTEMS ARE NON-CERVICAL SPINAL FIXATION DEVICES, WHICH UTILIZE POSTERIOR SCREWS AND HOOKS AND ANTEROLATERAL FIXATION. THE USS SYSTEMS ARE USED TO TREAT DEGENERATIVE DISK DISEASE, TRAUMAS AND DEFORMITIES/CURVATURES. THE HOOK/SCREW HOLDER IS SPECIFICALLY UTILIZED TO PLACE HOOKS ON AND INSERT DUAL-OPENING SCREWS INTO PREPARED PEDICLES. THE DRAWINGS FOR THE HOOK/SCREW HOLDER WERE REVIEWED: SPECIFICALLY THOSE RELATED TO THE PIN, THE SLEEVE AND THE TOP LEVEL, AND FOUND TO BE SUITABLE FOR THEIR INTENDED USE. THE HOOK/SCREW HOLDERS WERE FOUND TO HAVE MET THE DRAWING SPECIFICATIONS. A HOOK/SCREW HOLDER WITH 4.0MM HEX (388.612 LOT 4528220) WERE RECEIVED. THE HOLDER WAS RETURNED WITH THE 4MM BROKEN OFF THE THREADED DISTAL TIP OF THE PIN. THE FRACTURE SITE WAS EXAMINED UNDER MAGNIFICATION AND WAS FOUND TO BE HOMOGENOUS. AFTER REVIEWING THE RELATED PRODUCT DRAWINGS, COMPLAINT HISTORY AND RISK ASSESSMENT, NO DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED WHICH COULD HAVE CAUSED/CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED INSTRUMENT IS OVER 11 YEARS OLD. THE RETURNED PRODUCT WAS RECEIVED BROKEN; AS SUCH THE COMPLAINT IS CONFIRMED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THERE WERE NO RELEVANT ISSUES WERE FOUND DURING MANUFACTURING WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. ALL OTHER RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A T8-L2 POSTERIOR SPINAL FUSION WITH UNIVERSAL SPINAL SYSTEM DUAL OPENING WAS PERFORMED ON A PATIENT WITH A SPINE FRACTURE ON (B)(6) 2014. THE SURGEON INSTRUMENTED THE PATIENT FROM T8-L2 AND CONNECTED THE RODS. THE SURGEON TORQUED ALL NUTS AND COLLAR AND BEGAN REMOVING ALL THE HOOK/ SCREW HOLDERS USING A SMALL HEXAGONAL SCREWDRIVER .WHEN LOOSENING THE HOOK/ SCREW HOLDER FROM THE RIGHT L2 DUAL OPENING UNIVERSAL SPINAL SYSTEM SCREW THE TIP OF THE HOOK/ SCREW HOLDER BROKE OFF IN THE SCREW. THE SURGEON ELECTED TO NOT REMOVE THE SCREW LEAVING THE FRAGMENT IN THE SCREW, A PIECE REMAINED IN THE PATIENT. NO PATIENT HARM WAS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAYS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461903 HOOK/SCREW HOLDER WITH 4.0MM HEX MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES BRANDYWINE 4528220

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR