BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS

    MDR report key: 6210829 · Received December 28, 2016

    Report

    Report Number
    1719045-2016-10951
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Report Date
    December 2, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTJ
    UDI-DI
    10886982189936
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHEN THE DEVICE BROKE; IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). PART 319.004, SYNTHES LOT 7023847: RELEASE TO WAREHOUSE DATE: SEPTEMBER 12, 2012. MANUFACTURED BY SYNTHES (B)(4). REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED ON THE RETURNED DEVICE (DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS, PART # 319.00, LOT # 7023847). THE RETURNED DEPTH GAUGE WAS CONFIRMED TO BE MISSING THE NEEDLE. THE THREADS OF THE NEEDLE REMAIN IN THE SLIDER BODY. NONE OF THE NEEDLE OUTSIDE OF THE SLIDER BODY REMAINS. THE DEVICE IS OTHERWISE IN GOOD CONDITION WITH MINOR SURFACE WEAR AND SCRATCHES ON THE HANDLE WHICH DO NOT IMPACT FUNCTIONALITY. A VISUAL INSPECTION, DRAWING REVIEW AND DEVICE HISTORY RECORD (DHR) REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT IS CONFIRMED. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEPTH GAUGE IS ALREADY BROKEN. THE 319.004 DEPTH GAUGE IS INTENDED FOR USE IN MEASURING FOR 1.3MM AND 1.5MM SCREWS IN VARIOUS PLATING SYSTEMS AND IS LISTED IN TECHNIQUES GUIDES FOR HEADLESS COMPRESSION SCREWS, THE MODULAR HAND SYSTEM, AND THE ROTATION CORRECTION PLATE SYSTEM. THE DRAWINGS FOR DEPTH GAUGE FOR 1.3/1.5MM SCREWS WERE REVIEWED DURING INVESTIGATION. THE DESIGN HISTORY WAS NOT FOUND TO IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. THE BROKEN NEEDLE IS LIKELY DUE TO ROUGH HANDLING DURING USE OR PROCESSING. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTED THE FOLLOWING EVENT: THE DEPTH GAUGE NEEDLE BROKE OFF. NO ADDITIONAL INFORMATION AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861169 DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS GAUGE, DEPTH HTJ SYNTHES MONUMENT 7023847 10886982189936

    Patients

    Seq Age Sex Outcome Treatment
    1