BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 3784567 · Received May 1, 2014

    Report

    Report Number
    3003875359-2014-10090
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 2, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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 PRODUCT INSPECTION OF THE RETURNED INSERTION HANDLE, ARTICLE NUMBER 03.010.405 WAS FUNCTIONALLY TESTED ON (B)(6) 2014 WITH EQUIVALENT IMPLANTS AND INSTRUMENTATION TAKEN FROM DEMO SETS. THE INSTRUMENT FUNCTIONAL TESTING WAS DONE WITH TWO PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) NAILS (ARTICLE NUMBERS 04.027.191 LOT 7763987 AND 472.104 LOT 2470459). BOTH NAILS WERE CONNECTED TO THE INSERTION HANDLE WITH THE SAME CONNECTING SCREW (ARTICLE 357.029 LOT 2100580). THEN THE AIMING ARM (ARTICLE 03.010.407 LOT 2600408) WAS ATTACHED TO THE INSERTION HANDLE. NEXT THE GOLD AND GREEN PROTECTIONS SLEEVE, DRILL GUIDE, AND TROCAR INSTRUMENTATION WERE ASSEMBLED THROUGH THE AIMING ARM TO CHECK THE ALIGNMENT OF THOSE SLEEVES WITH THE RESPECTIVE SCREW HOLES IN THE TWO NAILS. THE TABLE BELOW GIVES THE ARTICLE AND LOT NUMBERS OF THE INSTRUMENTS USED. ARTICLE NUMBER LOT NUMBER INSTRUMENT: 356.831 2116053 PROTECTION SLEEVE, GREEN; 356.828 2542475 DRILL GUIDE, GREEN; 356.833 2125715 TROCAR, GREEN; 356.818 2136136 PROTECTION SLEEVE, GOLD; 356.819 2612454 DRILL GUIDE, GOLD; 356.820 2125710 TROCAR, GOLD. ALL THE INSTRUMENTS COULD BE ASSEMBLED AS INTENDED IN THIS FUNCTIONAL TEST. THE NAIL, INSERTION HANDLE, AIMING ARM, PROTECTION SLEEVE, DRILL GUIDE, AND TROCAR ASSEMBLY ALIGNED TO THE TARGETED HOLES ON BOTH NAILS. IN CONCLUSION, THE RETURNED INSERTION HANDLE WAS FUNCTIONAL WITH EQUIVALENT MATING PARTS. 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 HANDLE OF THE INSERTION DEVICE STOPPED WORKING. NO PATIENT WAS INVOLVED THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263247 RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 8417100

    Patients

    Seq Age Sex Outcome Treatment
    1