BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 3.5MM CORTEX SCREWS

    MDR report key: 2993920 · Received March 8, 2013

    Report

    Report Number
    3003787298-2013-00011
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED. THERE WERE NO ISSUES DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. 3 DEPTH GAUGES WERE RETURNED FOR EVALUATION. LOT NUMBER 6811755 WAS MANUFACTURED IN NOVEMBER 2011. LOT NUMBER 6552245 WAS MANUFACTURED IN DECEMBER 2010. LOT NUMBER 6527928 WAS MANUFACTURED IN NOVEMBER 2010. ALL THREE DEVICES HAVE BENT AND DAMAGED NEEDLES. TWO COMPLAINT CONDITIONS EXIST. THE SURGEON NOTED THAT SCREW LENGTH WAS NOT ACCURATE AND SCREW WAS OFF SIZED BY 2MM, AND THE CONSULTANT CHECKED ALL OF THE HOSPITALS DEPTH GAUGES AND NOTED THAT GAUGES WERE ASSEMBLED INCORRECTLY BY THE HOSPITAL STAFF DUE TO THE FACT THAT THE INTER PORTION OF THE GAUGE WAS NOT ETCHED FOR EASY ASSEMBLY. THE COMPLAINT CONDITION RELATED TO MIS-ASSEMBLED DEVICES COULD NOT BE REPLICATED DURING THIS EVALUATION BECAUSE THE DEPTH GAUGE BODY WILL ONLY MATE WITH THE SLIDER BODY IN ONE ORIENTATION. DUE TO COMPONENT GEOMETRIES, THERE IS NO PHYSICAL WAY TO MIS-ASSEMBLE THE TWO COMPONENTS AND THIS DEPTH GAUGE IS NOT INTENDED FOR USE IN TIBIA PROCEDURE. THE COMPLAINT DESCRIPTION ALSO STATES, THE SURGEON NOTED THAT SCREW LENGTH WAS NOT ACCURATE AND SCREW WAS OFF SIZED BY 2MM. THE 319.091 DEPTH GAUGE IS NOT INTENDED FOR USE WITH TIBIAL NAIL PROCEDURE, RATHER IT IS INTENDED FOR USE WITH THE LOW PROFILE PELVIC PLATE SYSTEM. THE PROPER DEPTH GAUGE TO USE FOR TIBIAL NAIL PROCEDURE IS PART NUMBER 03.010.072 PER THE TITANIUM CANNULATED TIBIAL NAIL TECHNIQUE GUIDE J6471-D. THIS IS THE ONLY COMPLAINT FOR BOTH COMPLAINT CONDITIONS IN THE ENTIRE COMPLAINT HISTORY. THE DESIGN WAS REVIEWED, IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO EITHER COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A MANUFACTURING AND/OR PRODUCT INVESTIGATION COULD NOT BE PERFORMED AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, DURING A TIBIA NAIL PROCEDURE, THE SURGEON USED A DEPTH GAUGE TO MEASURE SCREW LENGTH. THE SURGEON NOTED THE SCREW LENGTH WAS NOT ACCURATE AND THE SCREW WAS OFF SIZE BY 2MM. AS A RESULT, THE SURGEON SELECTED ANOTHER GAUGE AND COMPLETED THE PROCEDURE WITH NO ADVERSE EFFECT TO THE PATIENT. ALL OF THE HOSPITALS DEPTH GAUGES WHERE CHECKED AND NOTED THE GAUGES WERE ASSEMBLED INCORRECTLY BY THE HOSPITAL STAFF BECAUSE THE INNER PORTION OF THE GAUGES WERE NOT ETCHED FOR EASY ASSEMBLY. THIS IS OF 1 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100008 DEPTH GAUGE FOR 3.5MM CORTEX SCREWS HTJ SYNTHES JENNERSVILLE 6527928

    Patients

    Seq Age Sex Outcome Treatment
    1