BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULUS-STRUM. - ESTRATTORE CO

    MDR report key: 8801853 · Received July 18, 2019

    Report

    Report Number
    3008021110-2019-00083
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    April 7, 2019
    Report Date
    July 18, 2019
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    KWY
    PMA / PMN Number
    K112158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECK OF THE DHR: BY CHECKING THE MANUFACTURING CHART OF THE LOT #1213994, NO ANOMALY WAS FOUND ON THE 10 MODULUS EXTRACTORS MANUFACTURED WITH THIS LOT#. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED WITH THIS LOT #. INSTRUMENT ANALYSIS: WE RECEIVED THE BROKEN INSTRUMENT IN LIMA HEADQUARTERS FOR ANALYSIS. VISUAL INSPECTION SHOWED THE SCREW OF THE INSTRUMENT BROKEN AND IT WAS NOT POSSIBLE TO PERFORM ANY DIMENSIONAL OR FUNCTIONAL ANALYSIS. WE CAN HYPOTHESIZE THAT THE EVENT WAS DUE TO COLD WELDING - LINKED TO FRETTING - OCCURRED AT THE TAPER - STEM INTERFACE. FRETTING IS A PHENOMENON WELL KNOWN IN LITERATURE, WITH REFERENCE TO TI-TI TAPER CONNECTIONS LIKE THE MODULUS ONE. RESISTENCE DUE TO COLD WELDING BETWEEN THE NECK AND THE STEM WAS TOO HIGH TO ALLOW THE INSTRUMENT 9043.10.360 TO DISENGAGE THEM, CAUSING BREAKAGE OF THE INSTRUMENT ITSELF. PMS DATA: ON THE BASIS OF OUR PMS DATA, WE ARE AWARE OF 7 CASES OF BREAKAGE OF THE INSTRUMENT 9043.10.360 DUE TO COLD WELDING ON MORE THAN 234 INSTRUMENTS SOLD WORLDWIDE. NO CORRECTIVE ACTIONS IMPLEMENTED FOR THIS SPECIFIC CASE. LIMA CORPORATE WILL KEEP THE MARKET MONITORED. NOTE: THIS COMPLAINT WAS CLOSED IN MARCH 2020, BUT DUE TO INTERNAL ERROR THE REPORT WAS NEVER SUBMITTED, THEREFORE SUBMISSION IS MADE TODAY.

    Description of Event or Problem · 0

    INTRA-OPERATIVE ISSUE HAPPENED ON THE (B)(6) 2019. DURING SURGERY, THE SURGEON WAS TRYING TO DETACH ONLY THE FEMORAL NECK TO ADJUST NECK ANGLE, BUT THE NECK CANNOT BE DETACHED FROM THE STEM RESULTING IN BREAKAGE OF THE NECK EXTRACTOR (CODE 9043.10.360 - LOT #1213994). EVENTUALLY, THE SURGEON EXPLANTED BOTH THE NECK AND THE STEM. THE EVENT PROLONGED THE SURGERY OF THREE HOURS. EVENT OCCURRED IN JAPAN.

    Additional Manufacturer Narrative · 1

    BY CHECKING THE MANUFACTURING CHART OF THE LOT #1213994, NO ANOMALY WAS FOUND. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED WITH THIS LOT NUMBER. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    INTRA-OPERATIVE ISSUE HAPPENED ON THE (B)(6) 2019. DURING SURGERY, THE SURGEON WAS TRYING TO DETACH ONLY THE FEMORAL NECK TO ADJUST NECK ANGLE, BUT THE NECK CANNOT BE DETACHED FROM THE STEM RESULTING IN BREAKAGE OF THE NECK EXTRACTOR CODE 9043.10.360 LOT #1213994. EVENTUALLY, THE SURGEON EXPLANTED BOTH THE NECK AND THE STEM. THE EVENT PROLONGED THE SURGERY OF THREE HOURS. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594889 MODULUS-STRUM. - ESTRATTORE CO MODULUS-STRUM. - ESTRATTORE KWY LIMACORPORATE S.P.A. 9043.10.360 1213994

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization