BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10.5MM CANNULATED DRILL BIT

    MDR report key: 6101033 · Received November 14, 2016

    Report

    Report Number
    9612488-2016-10461
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 21, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: APRIL 23, 2013. NO DEVIATION OR NON-CONFORMANCE REPORTS WERE MARKED IN THE DEVICE HISTORY RECORD. 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 MANUFACTURING INVESTIGATION WAS PERFORMED ON THE SUBJECT DEVICE (10.5MM CANNULATED DRILL BIT, PART # 03.224.003, LOT # 8275357). THE PRODUCT WAS RETURNED IN A PACKAGING DIFFERENT FROM THE ORIGINAL PACKAGING. THE LASER MARKING WAS READABLE. THE CUTTING EDGE FROM THE DRILL BIT IS BROKEN. THE CUTTING EDGE SHOWS SCRATCHES AND THE DRILL BIT HAS DAMAGES. ALL DIMENSIONS RELEVANT FOR THE FUNCTION AND THE HARDNESS OF THE PRODUCT WERE MEASURED, AND FULFILL THE SPECIFICATIONS. THE LOT OF THE RAW MATERIAL OF ARTICLE 03.224.003 IS NOT TRACKED BY NUMBER. THEREFORE THE CHECK WAS DONE BASED ON FIFO (FIRST IN/FIRST OUT) BY INVESTIGATION OF THE RAW MATERIAL ORDER, WHICH WERE CLOSEST TO THE START OF THE MANUFACTURING ORDER OF THE COMPONENT. IT WAS FOUND THAT THE USED RAW MATERIAL FULFILLED THE SPECIFICATIONS. BASED ON THIS THE COMPLAINT IS RATED AS CONFIRMED BUT NOT VALID FROM THE POINT OF VIEW OF THE MANUFACTURING SITE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. NO INDICATION FOR PRODUCT RELATED ISSUE WAS FOUND. 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)REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A LOCKING COMPRESSION PLATE - DYNAMIC HIP SCREW SYSTEM (LCP-DHS) OPERATION ON (B)(6) 2016, THE TIP OF THE DRILL BIT BROKE WHEN THE SURGEON BROUGHT THE DRILL BIT ALONG THE WIRE IN CONTACT WITH EXTERNAL CORTICAL BONE AND STARTED TO DRILL. THE DRILL BIT BROKE BEFORE THE EXTERNAL CORTICAL BONE WAS SHAVED SO THERE WAS NO BODY RESIDUE. THERE WAS NO SURGICAL DELAY. THE DRILL WAS DAMAGED BEFORE THE EXTERNAL CORTICAL BONE WAS GROUND, SO THERE WAS NO FRAGMENT REMAINED IN THE BODY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750921 10.5MM CANNULATED DRILL BIT BIT, DRILL HTW SYNTHES BETTLACH 8275357

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR