BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION SCREWDRIVER

    MDR report key: 3121557 · Received May 21, 2013

    Report

    Report Number
    2520274-2013-02721
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DATE DEVICE RECEIVED FOR EVALUATION. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS REVEALED THAT THE EXTRACTION SCREWDRIVER WAS MANUFACTURED BY (B)(4) ON SUPPLIER LOT NUMBER 573166NN06. THIS LOT WAS RECEIVED AT SYNTHES AS LOT NUMBER 5414391. PO 701269, DATED 12/13/05, FOR (B)(4) PARTS, WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET NUMBER 352IF311 REVISION H ON 12/22/06. THE CERTIFICATE OF COMPLIANCE (C OF C) IS DATED 12/15/06. 35 PARTS WERE RELEASED TO THE WAREHOUSE ON 12/27/06. CAPA (B)(4) WAS ASSOCIATED WITH THESE LOT NUMBERS THAT INDICATES THE PARTS WERE NOT SUBJECTED TO NITRIC ACID PASSIVATION OR ELECTRO POLISH DURING MANUFACTURING, HOWEVER, ACCORDING TO THE RISK ASSESSMENT THIS SHOULD HAVE NO IMPACT ON THE COMPLAINT CONDITION. DETERMINED DURING DHR REVIEW. DUE TO AN UNKNOWN CAUSE THE TIP OF THE INNER SHAFT BROKE OFF AT THE THREAD BASE. THE MATERIAL AND DIAMETER OF THE INNER SHAFT AND OUTER SLEEVE WAS DETERMINED TO BE WITHIN SPECIFICATION. THE MATERIAL HARDNESS COULD NOT BE VERIFIED DUE TO THE SMALL SHAFT DIAMETER. ALL OF THE THREADS WHERE MISSING SO THE THREADS COULD NOT BE VERIFIED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS PERFORMED AND THE FOLLOWING WAS DOCUMENTED. THE EXTRACTION DRIVER IS USED FOR REMOVAL OF THE VECTRA AND ACCS SCREWS. THE INNER SHAFT THREADS INTO THE INNER THREAD OF THE SCREW. THE OUTER DRIVER SHAFT IS THEN USED TO UNSCREW THE SCREW FROM THE BONE. THE INNER SHAFT OF THE DRIVER WAS RETURNED WITH APPROXIMATELY ALL EXCEPT HALF OF A BROKEN THREAD REMAINING. THE THREAD FAILURE APPEARS TO HAVE OCCURRED FROM APPLYING A BENDING MOMENT, FORCE APPLIED PERPENDICULAR TO THE AXIS OF THE INSTRUMENT. THE FORCE APPEARS TO HAVE EXCEEDED THE TENSILE STRENGTH OF THE THREADED REGION OF THE SHAFT. THE THREADED SHAFT MAY NOT HAVE BEEN FULLY TIGHTENED DOWN TO THE SCREW AS DESCRIBED IN THE TECHNIQUE GUIDE. THE ENGINEER REVIEWED RELEVANT DRAWINGS . THE DRIVER INNER SHAFT WAS PRODUCED PRIOR TO THE MATERIAL CHANGE TO CUSTOM (B)(4). THE RISK ASSESSMENT DOES NOT INCLUDE ALL POSSIBLE HARMS SPECIFICALLY A DELAY DUE TO RETRIEVAL OF THE TIP AS IN THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    LOT NUMBER PROVIDED TO MANUFACTURER LOCATION REVEALED THAT LOT NUMBER WAS NOT VALID. AWARENESS DATE: (B)(6) 2013.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, A PATIENT WAS IMPLANTED WITH A VECTRA IMPLANT AND SCREWS. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED NON-UNION. ON (B)(6) 2013, THE PATIENT UNDERWENT A VECTRA ANTERIOR CERVICAL FUSION REVISION SURGERY DUE TO THE NON-UNION. THE VECTRA IMPLANT AND FOUR SCREWS WERE REMOVED. WHILE THE SURGEON WAS REMOVING THE DISTAL SCREW ON THE VECTRA IMPLANT, THE INNER PORTION OF THE EXTRACTION SCREWDRIVER TIP BROKE. IT WAS SWAPPED FOR ANOTHER DRIVER THAT WAS READILY AVAILABLE. THE SURGERY WAS NOT PROLONGED. THE PATIENT WAS REVISED TO A ZERO-P IMPLANT. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224801 EXTRACTION SCREWDRIVER HXX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1