BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCRDRIVER T8 SELF-HOLD ANGL W/SLEEVE

    MDR report key: 2823591 · Received October 9, 2012

    Report

    Report Number
    8030965-2012-01016
    Event Type
    Malfunction
    Date Received
    October 9, 2012
    Date of Event
    August 9, 2012
    Report Date
    September 10, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    K112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS SHOWN THAT THE TIP OF THE SCREWDRIVER IS INDEED BROKEN OFF AS COMPLAINED. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS INSTRUMENT WAS MANUFACTURED IN JUNE 2008 ACCORDING TO THE SPECIFICATIONS. NO ABNORMAL FINDINGS WERE IDENTIFIED. THE BROKEN SURFACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY TO THE SPECIFICATION AS WELL. BASED ON THESE RESULTS IT IS CONCLUDED THE CAUSE OF THE FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES AND IT IS ASSUMED THAT EXCEEDING APPLIED MECHANICAL FORCE LED TO THE BREAKAGE OF THE TIP. THE ARTICLE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT ENTERING THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A C4/5/6 ACDF PROCEDURE SURGEON INSERTED A ZERO-P CAGE AND WAS UNABLE TO DRILL THE HOLE FOR THE SCREW THROUGH THE AIMING DEVICE. SURGEON THEN USED AN ANGLED AWL TO BREAK THE CORTEX AND THEN USED A T8 SCREWDRIVER TO INSERT THE SCREW. SURGEON HAD PROBLEMS INSERTING THE SCREW AND THE TIP OF THE SCREWDRIVER BROKE OFF. THE BROKEN TIP IS THOUGHT TO HAVE BEEN CAPTURED BY SUCTION. SURGEON WAS ABLE TO TIGHTEN THE SCREW WITH A STRAIGHT DRIVER AND COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCRDRIVER T8 SELF-HOLD ANGL W/SLEEVE SCRDRIVER T8 HXX SYNTHES GMBH 1908130

    Patients

    Seq Age Sex Outcome Treatment
    1 SCRDRIVER, SCREW