BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK/SCREW HOLDER WITH 4.0MM HEX

    MDR report key: 3103161 · Received May 9, 2013

    Report

    Report Number
    2520274-2013-02489
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. REVIEW OF DEVICE HISTORY RECORDS WAS PERFORMED AND REPORT STATES THE FOLLOWING: RECORDS FOR LOT # 4528222 REVEALED THE HOOK/SCREW HOLDER WITH 4.0MM HEX WAS MANUFACTURED BY ENVISION MANUFACTURING. (B)(4) PARTS WERE INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER (B)(4) ON (B)(4) 2003. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. THE CERTIFICATE OF COMPLIANCE (C OF C) IS DATED (B)(4) 2003. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON 6/3/2003. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. PDE EVENT- THE 388.612 IS A SCREW/HOOK HOLDER FOUND IN THE DUAL OPENING USS SPINAL SYSTEM (TECHNIQUE GUIDE J3985-G). THE HOOK/SCREW HOLDER IS USED IN COMBINATION WITH THE HANDLE (388.622) TO RETAIN AND INSERT THE DUAL OPENING SCREWS AND HOOKS INTO THE PEDICLES. THE LOT # 4528222 WAS RECEIVED ON 5/28/2003. THIS LOT WAS MANUFACTURED TO REV D OF DRAWING 388_612_1. HOWEVER, THERE ARE NO CHANGES TO MATERIAL OR DIMENSIONS OF THE RELEVANT THREAD DESIGN IN THE LATEST REV E THAT CHANGE THE STRENGTH OF THE THREADED TIP. THE MATERIAL (17-4 PH HEATREADED SS) IS ADEQUATE FOR THE DEVICES INTENDED USE. SINCE TORQUE IS ONLY APPLIED THROUGH THE HEX FEATURE WHEN FULLY ENGAGED IN THE SCREW, THE SURGEON MAY HAVE APPLIED A BENDING LOAD WHICH EXCEEDED THE TENSILE STRENGTH OF THE MATERIAL CAUSING THE FRACTURE. (B)(4). THE MANUFACTURING AND VISUAL EVALUATION REVEALED THE DAMAGE ON THE M8 THREAD, BROKEN PIECE OF INSTRUMENT PROTRUDING FROM THE M2.5 INTERNAL THREAD AND NICKS ON THE EDGES ON TOP OF THE HEX. THIS IS NOT MANUFACTURE RELATED. BECAUSE OF THE RETURNED CONDITION OF THE SCREW, NOT ALL RELEVANT FEATURES CAN BE VERIFIED; THEREFORE, THIS COMPLAINT IS INDETERMINATE.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. MANUFACTURE EVALUATION- THREADED TIP OF THE PIN IS BROKEN OFF AND WAS NOT SENT BACK FOR INVESTIGATION. CONCLUSION: THE RELEVANT DIMENSIONS CAN NOT BE VERIFIED ANYMORE BECAUSE THE BROKEN FRAGMENT WAS NOT SENT BACK FOR INVESTIGATION. THEREFORE THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY, AND HAS THE TYPICAL VIEW OF A FORCED RUPTURE. THE HEXAGON OF THE ENCLOSED SCREW IS BADLY DEFORMED. THIS INDICATES THAT EXCESSIVE FORCES WERE APPLIED ONTO THIS INSTRUMENT AND MAY BE INDICATIVE THAT A MECHANICAL OVERLOAD CAUSED THIS BREAKAGE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A L5 S1 FUSION SURGERY ON (B)(6) 2013, WHILE THE SURGEON WAS IMPLANTING A SCREW IN PEDICLE IN PATIENTS LUMBAR SPINE (UNKNOWN PEDICLE LOCATION), THE THREADS OF SCREW HOLDER BROKE IN THE HEAD OF THE SCREW. THE SURGEON WAS ABLE TO TAKE OUT AND REPLACE IT WITH A NEW ONE. THE SURGEON THEN ATTEMPTED TO PERSUADE THE ROD TO THE HEAD OF A SCREW DURING THE SAME PROCEDURE, USING A MALLET HOOK POSITIONER TO SEAT THE COLLAR ONTO THE ROD AND THE SCREW, WHEN THE PERSUADER BROKE. THE SURGEON THEN USED A NEW PERSUADER AND WAS ABLE TO COMPLETE THE PROCEDURE WITH NO ADVERSE EVENT TO PATIENT. THIS REPORT IS FOR A HOOK/SCREW HOLDER WITH 4.0MM HEX. THIS IS 1 OF 2 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203198 HOOK/SCREW HOLDER WITH 4.0MM HEX LXH SYNTHES BRANDYWINE 4528222

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR