BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM 130° F/PFNA BLADE

    MDR report key: 4124859 · Received September 29, 2014

    Report

    Report Number
    2520274-2014-13843
    Event Type
    Malfunction
    Date Received
    September 29, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 3, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN AIMING ARM, TWO DEVICES WERE INCLUDED IN THE COMPLAINT IT HAS NOT YET BEEN DETERMINED WHICH ONE WAS INVOLVED IN THIS EVENT. THE POSSIBLE PART AND LOT NUMBERS ARE AS FOLLOWS: PART NUMBER 03-010-406 LOT NUMBER 7841813 AND 03-010-407 LOT NUMBER 7841820. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 EVALUATION WAS COMPLETED: THE RETURNED PRODUCTS HAVE BEEN ASSEMBLED WITH STANDARD IMPLANTS AND ALSO STANDARD INSTRUMENTS HAVE BEEN USED TO COMPARE THEIR FUNCTION WITH THE RETURNED INSTRUMENTS DURING A SIMPLE FUNCTION AND HANDLING TEST. NO DYSFUNCTION COULD BE OBSERVED, THE DRILL BIT IS ALWAYS TARGETING THE MIDDLE OF THE DISTAL HOLE. THE FAILURE MODE COULD NOT BE REPRODUCED WITH THE RETURNED PRODUCTS AND WITH STANDARD PRODUCTS. CONSIDERING THE AVAILABLE DATA AND THE TEST PERFORMED THE LISTED ARTICLES CAN BE CONSIDERED AS SAFE AND EFFICIENT. A MALFUNCTION COULD NOT BE FOUND. THE MANUFACTURING DOCUMENTATION WAS ALSO REVIEWED AND THESE LOTS WERE PRODUCED AND RELEASED MEETING ALL SPECIFICATIONS. NO ACTUAL PRODUCT FAULT COULD BE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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: IT WAS REPORTED A DRILL BIT INTERFERED WITH THE NAIL AND THE TIP OF THE DRILL BIT (ABOUT 3 MM LENGTH) WAS BROKEN. A BROKEN PIECE REMAINED IN THE BONE, BUT THE OPERATION WAS FINISHED. THE OPERATION WAS EXTENDED FOR 20 MINUTES. THIS REPORT IS FOR THE UNKNOWN AIMING ARM. THIS IS REPORT 4 OF 5 FOR (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 4 OF 9 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604429 AIM-ARM 130° F/PFNA BLADE GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES BETTLACH 7841820

    Patients

    Seq Age Sex Outcome Treatment
    1