BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM TI CORTEX SCREW SELF-TAPPING 10MM

    MDR report key: 4100746 · Received September 19, 2014

    Report

    Report Number
    2520274-2014-13732
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    MQN
    PMA / PMN Number
    PK981275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE BROKE DURING REMOVAL; DEVICE WAS NOT EXPLANTED. A MANUFACTURING EVALUATION WAS COMPLETED: ONLY THE SCREW HEAD IS AVAILABLE; THE BROKEN OFF PORTION IS MISSING. BOTH OF THE RECEIVED CORTEX SCREWS ARE BROKEN APPROXIMATELY 1MM BENEATH THE SCREW HEADS. THE SCREWS WERE REPORTED TO BELONG TO ARTICLE NUMBERS 400.810 AND 401.812. BECAUSE OF THE DAMAGE AND MISSING THREADED SHAFTS AN EXACT ARTICLE NUMBER IDENTIFICATION IS NOT POSSIBLE ANYMORE. THE LOT NUMBERS ARE UNKNOWN WHAT MAKES IMPOSSIBLE TO CHECK THE MANUFACTURING AND RAW MATERIAL DOCUMENTS. DUE TO THE DAMAGE THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. THE COMPLAINTS STATISTICS OF THESE ARTICLE NUMBERS DO NOT SHOW AN INCREASED BREAKAGE RATE. THE SURFACES OF THE CROSS-SECTIONS SHOW THE TYPICAL VIEW OF A FORCED RUPTURE; NO ANOMALIES OF MATERIALS STRUCTURE ARE VISIBLE. IT IS LIKELY THESE BREAKAGES TO BE CAUSED DURING MECHANICAL OVERLOADING SITUATIONS. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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: THE COMPLAINT RECEIVED STATES THAT THE PATIENT WAS UNDERGOING REMOVAL OF IMPLANT FROM THE LEFT HAND ON THE 4TH METACARPAL. THE SCREW HEAD OF 1.5 CORTICAL SCREW, LENGTH 10MM BROKE WHILE REMOVING WITH A HAND MODULAR SCREW DRIVER. THE SHAFT OF THE SCREW WAS LEFT IN THE PATIENT. THE SCREW HEAD OF 2.0 CORTICAL SCREW, LENGTH 12MM BROKE WHILE REMOVING WITH A HAND MODULAR SCREW DRIVER. THE SHAFT OF THE SCREW WAS LEFT IN THE PATIENT. IT WAS REPORTED THAT THE PATIENT DOES NOT HAVE EXISTING HEALTH PROBLEMS, PATIENT WAS NOT HARMED. THE SURGERY WAS NOT PROLONGED. THIS IS REPORT NUMBER 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582025 1.5MM TI CORTEX SCREW SELF-TAPPING 10MM MANDIBLE DISTRACTION DEVICES MQN SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR