BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING

    MDR report key: 3010193 · Received March 19, 2013

    Report

    Report Number
    8030965-2013-00997
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADDITIONAL INFORMATION, NOT PREVIOUSLY. THE FIRST COMPONENT 03.617.900.001 THE COMPLETE T8 PORTION BROKE OFF THE U-JOINT. ON THE SECOND COMPONENT 03.617.900.001 THE U-JOINT IS BENT AND DAMAGED. BOTH DEVICES SHOW WEAR OF FRICTION CAUSED BY THE MISSING OUTER SLEEVES. A MANUFACTURING CONCLUSION CANNOT BE PRESENTED DUE TO THE CONDITION OF THE PRODUCTS. VISUALLY THERE DOES NOT APPEAR TO BE AN ISSUE OTHER THAN THE DAMAGE SUSTAINED BY IMPLANTATION AND EXTRACTION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THE TECHNIQUE GUIDE FOR THE ZERO-P INSTRUMENTS AND IMPLANTS RECOMMENDS TO TIGHTEN THE SCREW TO THE PLATE WITH 1.2 NM USING A TORQUE LIMITING ATTACHMENT (03.110.002.99). THE TECHNIQUE GUIDE ALSO INSTRUCTS THE SURGEON TO USE THE ANGLED INSTRUMENTS IF THE PATIENT ANATOMY DOES NOT ALLOW USE OF STRAIGHT INSTRUMENTS. PART NUMBER 03.617.900 IS AN ANGLED INSTRUMENT AND CONSISTS OF THREE COMPONENTS - DRIVER, SLEEVE, AND HANDLE. THIS COMPLAINT INVOLVES THE DRIVER COMPONENT. SPECIFICALLY, THE DISTAL TIP OF THE DRIVER IS OF CONCERN. THE ENGINEER REVIEWED THE ASSEMBLY DRAWINGS OF THE DISTAL TIP. THE DISTAL TIP INVOLVES SEVEN PARTS AND SIX WELDMENTS. THE FAILURE MODES FOR A BROKEN TIP ARE SEVERAL. THE DRAWING REQUIRES A MINIMUM PASSING TORQUE OF 1.8 NM BEFORE ASSEMBLING THE UNIVERSAL JOINT. THE DESIGN & CLINICAL RISK MANAGEMENT FOR ZERO-P WAS ALSO REVIEWED BY THE ENGINEER. THE FAILURES OF THE DISTAL TIP ARE DUE TO STRESSES THAT EXCEED THE MATERIAL OR WELD STRENGTH. SINCE THE FORCE DELIVERED BY THIS INSTRUMENT IS NOT TORQUE LIMITING, THE AMOUNT OF TIGHTENING TORQUE IS UNKNOWN. ACCORDING TO THE RISK ASSESSMENT, TORQUES ABOVE AND BELOW THE RECOMMENDED 1.2 NM PRESENT CLINICAL RISKS ASSOCIATED WITH THE SUCCESS OF THE PROCEDURE. IN ADDITION, DELIVERING A TORQUE BEYOND THE STRENGTH OF THE INSTRUMENT CAN LEAD TO BREAKAGE OF THE DEVICE. A DETERMINATION OF AN INTERNAL CORRECTION ACTION TO ADDRESS THIS ISSUE HAS BEEN INITIATED. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. INVESTIGATION IS ON-GOING.

    Description of Event or Problem · 1

    DURING AN ACDF PROCEDURE, IT WAS REPORTED THE HEX ADAPTOR BROKE WHILE TIGHTENING A SCREW. ADDITIONALLY, THE UNIVERSAL SCREWDRIVER (PART 03.617.900.001) OF THE ANGLED STARDRIVE SCREWDRIVER T8 BROKE AT THE U-JOINT WHILE TIGHTENING A SCREW. SUBSEQUENTLY, A SECOND UNIVERSAL SCREWDRIVER (PART 03.617.900.001) OF THE ANGLED STARDRIVE SCREWDRIVER T8 BROKE AT THE U-JOINT AS WELL. NO FRAGMENTS WERE REPORTEDLY IN THE OPERATIVE SITE. THE PROCEDURE WAS COMPLETED USING BACK UP PARTS WITH NO INJURY TO PATIENT AND NO DELAY. THIS REPORT IS FOR TWO ANGLED STARDRIVE SCREWDRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113188 ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING OVE SYNTHES GMBH 7964797

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR