BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULUS-STR.-COLLO DI PROVA CO

    MDR report key: 11301414 · Received February 9, 2021

    Report

    Report Number
    3008021110-2021-00006
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Date of Event
    January 7, 2021
    Report Date
    June 4, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JDI
    PMA / PMN Number
    K112158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING RECORDS WERE CHECKED CONFIRMING THE BATCH NUMBER INVOLVED WAS MANUFACTURED CORRECTLY UP TO SPECIFICATION AND IN-LINE WITH THE RELEVANT CHECKS AND TESTS. NO MANUFACTURING DEVIATIONS WERE REPORTED. NO OTHER COMPLAINTS RECEIVED ON THE SAME LOT#. DEVICE ANALYSIS DIMENSIONAL ANALYSIS ON THE RETURNED ITEM (SCREW ONLY, AS PER IMAGE 1) HAVE BEEN PERFORMED WITH THE FOLLOWING RESULTS: IN ADDITION, A TOLERANCE ANALYSIS FOR THE MODULUS: TRIAL LOCKING SCREWS FOR NECK-STEM WAS CARRIED OUT WITH FOCUS ON THE DIMENSIONS THAT COULD HAVE GENERATED A POTENTIAL RISK OF BREAKAGE. IN BOTH NOMINAL/WORST CASES THE RESISTANT SECTION WAS CONSIDERED ACCEPTABLE CONFIRMING THE CORRECTNESS OF THE DIMENSIONS/TOLERANCES SET IN THE TECHNICAL DRAWING. ROOT CAUSE ANALYSIS BASED ON THE ANALYSIS PERFORMED, SCREW'S BREAKAGE COULD HAVE OCCURRED DUE TO A PEAK OF FORCE EXERTED BY THE USER ON THE SCREW DURING THE SURGERY OR BECAUSE THE SCREW HAD ALREADY BEEN PREVIOUSLY OVERSTRESSED AND THEREFORE IT TOOK LITTLE TO BREAK IT. EVENT NOT PRODUCT RELATED. PMS DATA ACCORDING TO THE PMS DATA, A TOTAL OF 2 (TWO) SIMILAR COMPLAINTS (INCLUDING THIS ONE) HAVE BEEN REPORTED TO LIMACORPORATE ON THE SPECIFIC PRODUCT CODE 9043.10.400 ON A TOTAL OF 453 PIECES MANUFACTURED GIVING AN OCCURRENCE RATE OF (B)(4) . PLEASE CONSIDER THIS OCCURRENCE RATE AS A OVERESTIMATION BY CONSIDERING INSTRUMENTS AS REUSABLE DEVICE. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE.

    Description of Event or Problem · 0

    DURING SURGERY ON (B)(6) 2021, WHEN THE SURGEON WAS TRYING TO FIX THE MODULUS-STR.-COLLO DI PROVA CORTO 125# CONO B (PRODUCT CODE 9043.10.430, LOT #J105000400) WITH THE TRIAL LOCKING SCREW, THE SCREW BROKE. BROKEN PIECE WAS REMOVED FROM THE PATIENT, AND NO RESIDUAL ON THE PATIENT WAS CONFIRMED. DUE TO THE EVENT, THE SURGERY WAS PROLONGED FOR ABOUT 10 TO 15 MINUTES.

    Additional Manufacturer Narrative · 1

    BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE INSTRUMENTS MANUFACTURED WITH LOT# J105000400. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT#. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    DURING SURGERY ON (B)(6) 2021, WHEN THE SURGEON WAS TRYING TO FIX THE MODULUS-STR.-COLLO DI PROVA CORTO 125# CONO B (PRODUCT CODE 9043.10.430, LOT #J105000400) WITH THE TRIAL LOCKING SCREW, THE SCREW BROKE. DUE TO THE EVENT, THE SURGERY WAS PROLONGED FOR ABOUT 15 MINUTES. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202304 MODULUS-STR.-COLLO DI PROVA CO TRIAL NECK SHORT 125° TAPER B JDI LIMACORPORATE S.P.A. 9043.10.430 J105000400

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O