BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREW 6,5 H.30MM

    MDR report key: 10023424 · Received May 5, 2020

    Report

    Report Number
    3008021110-2020-00028
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Date of Event
    April 30, 2020
    Report Date
    April 20, 2021
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K172456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BY CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOT#, NO PRE-EXISTING ANOMALY WAS FOUND ON A TOTAL OF 200 ITEMS MANUFACTURED WITH THE SAME LOT#. ACCORDING TO OUR RECORDS, AT LEAST 103 OUT OF 200 BONE SCREWS WITH LOT #1920567 HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT #. UPON REQUEST OF THE SURGEON, THE EXPLANTED METAL SHARDS OF THE SCREW WAS ANALYZED BY THE BIOENGINEERING DEPARTMENT OF THE HOSPITAL. THE FINAL REPORT WAS MADE AVAILABLE TO LIMACORPORATE. THE REPORT DOES NOT HIGHLIGHT SIGNIFICANT CONCLUSION. IT STATES THAT "FROM A PURELY MATERIALS VIEW POINT THERE ARE NO ADVERSE FEATURES NOTED". POST-OPERATIVE X-RAYS WERE REQUESTED TO THE COMPLAINT SOURCE BUT WERE NOT AVAILABLE FOR THE CASE. INVESTIGATIONS PERFORMED ON SIMILAR COMPLAINTS RECEIVED BY LIMACORPORATE SHOWED THAT INTRA-OPERATIVE SCREW BREAKAGE COULD BE EXPERIENCED DUE TO THE EXCESSIVELY HIGH TORQUE APPLIED TO THE SCREW UPON SCREWING. BESIDES, THE CORRECT ALIGNMENT OF THE SCREWDRIVER WITH THE SCREW AND THE PROPER PLACEMENT OF IT ON THE HEAD OF THE SCREW MAINTAINED DURING THE SCREWING ACTION PREVENT THE BREAKAGE OF THE SCREW. WE CANNOT INVESTIGATE FURTHER THE ISSUE, HOWEVER STATING THAT: THE REPORT FROM THE BIOENGINEERING DEPARTMENT FOUND NO ADVERSE FEATURES ON THE MATERIAL; NO ANOMALIES WERE DETECTED FROM THE ANALYSIS OF THE MANUFACTURING CHARTS OF THE PRODUCT, WE CAN CONCLUDE THAT THE EVENT IS NOT PRODUCT RELATED. PMS DATA: ACCORDING TO LIMACORPORATE PMS DATA, WE CAN ESTIMATE THE INTRA-OPERATIVE BREAKAGE OF BONE SCREWS - BELONGING TO THE FAMILY CODES 8420.15.XXX - TO BE VERY LOW (<0,01%). NO SPECIFIC CORRECTIVE ACTIONS IMPLEMENTED IN RELATION TO THIS CASE. LIMA CORPORATE KEEPS MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    INTRA-OPERATIVE ISSUE OCCURRED ON (B)(6) 2020: WHILE THE SURGEON WAS SCREWING THE BONE SCREW (CODE 8420.15.030, LOT# 1920567) INTO THE METAL BACK GLENOID HOLE, THE SCREW HEAD BROKE. THE SCREW WAS LEFT IN SITU, THE SURGEON DRILLED IT TO ALLOW A SECURE ENGAGEMENT OF THE LINER AND THEN REMOVED ALL THE METAL SHARDS. THIS ISSUE CAUSED 30 MINUTES OF PROLONGED SURGERY TIME. EVENT HAPPENED IN AUSTRALIA.

    Additional Manufacturer Narrative · 1

    BY THE CHECK OF THE DHRS, NO PRE-EXISTING ANOMALY WAS FOUND ON THE BONE SCREWS BELONGING TO LOT# 1920567. FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT#. WE WILL SUBMIT A FINAL MDR AFTER THE FINAL INVESTIGATION.

    Description of Event or Problem · 1

    INTRA-OPERATIVE ISSUE OCCURRED ON (B)(6) 2020: WHILE THE SURGEON WAS SCREWING THE BONE SCREW (CODE 8420.15.030, LOT# 1920567) INTO THE METAL BACK GLENOID HOLE, THE SCREW HEAD BROKE. THE SCREW WAS LEFT IN SITU, THE SURGEON DRILLED IT TO ALLOW A SECURE ENGAGEMENT OF THE LINER AND THEN REMOVED ALL THE METAL SHARDS. THIS ISSUE CAUSED 30 MINUTES OF PROLONGED SURGERY TIME. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486566 BONE SCREW 6,5 H.30MM BONE SCREWS DIA. 6.5 X H. 30 MM LPH LIMACORPORATE S.P.A. 8420.15.030 1920567

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization