BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM UNIVERSAL DRILL GUIDE

    MDR report key: 10643992 · Received October 7, 2020

    Report

    Report Number
    8030965-2020-07793
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Report Date
    September 15, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER IS A SYNTHES EMPLOYEE. PART: 323360, LOT: 26P0858, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 08.JAN 2020 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. THE SHIPPED BACK DEVICE ¿UNIV-DRILL-GUIDE 3.5¿ ARTICLE NUMBER 323.360 WITH LOT NUMBER 26P0858 IS HEAVILY DEFORMED, IN PARTICULAR ON THE TWO COMPONENTS 50101359 (BOHRHÜL 2.5/3.5 2.6/3.5*41.3) AND 50110159 (DRUCKFEDER Ø5*19*0.4). COMPONENT 50101359 IS BENT AND IT LOOKS AS IF IT HAS BEEN CRUSHED ON THE TOOTHED END BY PLIERS WITH A LOT OF FORCE. COMPONENT 50110159 WAS FOUND STUCK IN THE THREAD OF COMPONENT 50101354 AND IT IS VISIBLY DEFORMED ON ONE OF THE EXTREMITIES (RING IS ENLARGED). THE FOLLOWING DOCUMENTS WERE REVIEWED: DEVICE HISTORY RECORD (DHR) 16661459; INSPECTION SHEET, ¿PA INTERN MULTIPLE 323.360/-US ¿; ¿UNIVERSALBOHRBUECHSE 3.5 KPL¿; ¿UNI-BOHRBUECHSENHALTER 3.5 KPL.¿; ¿BOHRHUELSE 2.5/3.5¿; ¿DRUCKFEDER D=0.4 / DE=5 / L=19¿. IN ORDER TO PERFORM THE INVESTIGATION, ALL THE DOCUMENTS MENTIONED ABOVE, VALID WHEN THE DEVICE WAS MANUFACTURED, HAVE BEEN ANALYZED. THE MANUFACTURING PROCESS WAS EXECUTED ACCORDING TO THE ANALYZED DOCUMENTS AND NO ANOMALIES WERE IDENTIFIED. THE DEVICE CANNOT PASS FUNCTIONAL TESTS SINCE THE COMPONENTS DEFORMED ARE PREVENTING THE FUNCTIONALITY OF THE DEVICE. A DIMENSIONAL INSPECTION HAS BEEN PERFORMED ON THE RETURNED DEVICE ¿UNIV-DRILL-GUIDE 3.5¿ ARTICLE NUMBER 323.360 WITH LOT NUMBER 26P0858 TO CONFIRM THE VISUAL INSPECTION. IN FACT, SINCE THE COMPLAINT PART IS DEFORMED, THE RESULTS WILL BE OUT OF SPECIFICATIONS. COMPONENT (B)(4): ACCORDING TO DRAWING, THE EXTERNAL DIAMETER IS OUTSIDE SPECIFICATIONS. IN FACT, SINCE THE MEASURED END IS DEFORMED, BY ROTATING THE COMPONENT DIFFERENT VALUES ARE MEASURED. COMPONENT (B)(4): ACCORDING TO DRAWING, THE OUTER DIAMETER ON ONE END (OUT OF SPECIFICATIONS VALUE) AND IN THE MIDDLE (INSIDE SPECIFICATIONS). SINCE THE COMPONENT 50110159 IS DEFORMED, MEASURING IN DIFFERENT POINTS RESULTS WILL HAVE DIFFERENT VALUES THAT WILL BE OUTSIDE SPECIFICATION WHERE THE COMPONENT IS MORE DEFORMED. ACCORDING TO EVIDENCE IS NOT POSSIBLE TO ADDRESS THE FINAL ROOT CAUSE TO A MANUFACTURING ISSUE. MOST LIKELY A MISHANDLING OF THE DEVICE LED TO THE OPENING OF THIS COMPLAINT. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN SURGERY THAT THE INNER DRILL SLEEVE WAS DAMAGED AND THE SPRING MECHANISM NO LONGER WORKED. THIS REPORT IS FOR ONE (1) 3.5MM UNIVERSAL DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111050 3.5MM UNIVERSAL DRILL GUIDE GUIDE FZX OBERDORF SYNTHES PRODUKTIONS GMBH 26P0858

    Patients

    Seq Age Sex Outcome Treatment
    1