BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTION SCREW FOR PFNA AIMING ARM

    MDR report key: 4095330 · Received September 17, 2014

    Report

    Report Number
    9612488-2014-10390
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    LXH
    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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED THE 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    ADDITIONAL NARRATIVE: (B)(6). A MANUFACTURING EVALUATION WAS COMPLETED: THE INVESTIGATION HAS SHOWN THAT THE THREADED TIP IS INDEED COMPLETELY BROKEN OFF AS COMPLAINED. THE MARKINGS ON THE SURFACE CLEARLY INDICATE THAT THIS INSTRUMENT HAS BEEN OFTEN USED OVER THE YEARS. IT IS LIKELY THAT A MECHANICAL OVERLOADING (DURING HAMMERING) FINALLY RESULTED IN THE BREAKAGE OF THE TIP. THE TECHNIQUE GUIDE SPECIFICALLY STATES ¿TO USE ONLY LIGHT BLOWS ON THE CONNECTOR FOR INSERTION HANDLE. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT NUMBER 2802648 MANUFACTURED IN JANUARY 2012. ADDITIONALLY A REVIEW OF OUR COMPLAINTS HISTORY SHOWS NO OTHER COMPLAINTS FOR THIS ISSUE FROM THIS LOT NUMBER. NO PRODUCT FAULT COULD BE DETERMINED. 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 THE CONNECTION SCREW FOR PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) AIMING ARM. THREADED TIP SNAPPED OFF, LEADING TO 15 MINUTES DELAY IN THE SURGICAL PROCEDURE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574792 CONNECTION SCREW FOR PFNA AIMING ARM MISC ORTHO SURGICAL INSTR LXH SYNTHES BETTLACH 2802648

    Patients

    Seq Age Sex Outcome Treatment
    1