BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM HEXAGONAL SCREWDRIVER SHAFT SELF-RETAINING

    MDR report key: 5644665 · Received May 10, 2016

    Report

    Report Number
    9612488-2016-10232
    Event Type
    Malfunction
    Date Received
    May 10, 2016
    Date of Event
    April 20, 2016
    Report Date
    April 20, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    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. A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (3.5MM HEXAGONAL SCREWDRIVER SHAFT SELF-RETAINING, PART NUMBER 314.152, LOT NUMBER 2790991). A VISUAL INSPECTION OF THE RETURNED INSTRUMENT CLEARLY SHOWS THAT THE HEXAGONAL TIP IS WORN OUT. THE EDGES ARE ROUNDED DUE TO MULTIPLE USE AND INCOMPLETE INSERTION INTO THE SCREW HEADS WHICH RESULTED IN HIGH MECHANICAL FORCE LEADING TO THE ROUNDING. THE CONDITION IS CONSIDERED NORMAL WEAR AND TEAR AS SUCH INSTRUMENTS MUST BE REPLACED. THIS DEVICE WAS MANUFACTURED IN OCTOBER 2011. THE COMPLAINT CONDITION WAS CONFIRMED. THE ROOT CAUSE IS DEVICE WORN FROM NORMAL USE AND SERVICING. NO PRODUCT FAULT COULD BE DETECTED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4): A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE 3.5MM SELF-RETAINING SCREWDRIVER SHAFT WOULD NOT RETAIN THE SCREW. THE PROBLEM WAS DISCOVERED DURING AN INSTRUMENT CHECK AFTER USE. IT IS UNKNOWN IF THIS PROBLEM ALSO OCCURRED DURING THE INTENDED TOMOFIX SURGICAL PROCEDURE. THERE WAS NO REPORT OF SURGICAL DELAY OR PATIENT HARM. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298349 3.5MM HEXAGONAL SCREWDRIVER SHAFT SELF-RETAINING SCREWDRIVER HXX SYNTHES BETTLACH 2790991

    Patients

    Seq Age Sex Outcome Treatment
    1