BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCREWS DIA. 6.5 X H. 35 MM

    MDR report key: 13891770 · Received March 24, 2022

    Report

    Report Number
    3008021110-2022-00018
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    January 31, 2022
    Manufacturer
    LIMACORPORATE SPA
    Product Code
    LPH
    PMA / PMN Number
    K172456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE SCREWS THAT BELONG TO LOT NUMBER 2006390 STER. 2000206. NO OTHER SIMILAR COMPLAINTS RECEIVED ON THIS LOT NUMBER. A FINAL REPORT WILL BE SUBMITTED AFTER THE CONCLUSION OF THE INVESTIGATIONS.

    Additional Manufacturer Narrative · 0

    CHECK OF THE DEVICE HISTORY RECORDS BY THE CHECK OF THE DEVICE HISTORY RECORDS, NO PRE-EXISTING ANOMALY WAS DETECTED ON THE SCREW WITH LOT NUMBER 2006390. ACCORDING TO OUR RECORDS, AT LEAST 137 SCREWS WITH LOT NUMBER 2006390 (OUT OF 200 MANUFACTURED) HAVE ALREADY BEEN IMPLANTED AND THIS IS THE FIRST AND ONLY SIMILAR INTRA-OPERATIVE INCIDENT REGISTERED ON THEM. RETRIEVED SCREW ANALYSIS THE SCREW REMAINED IMPLANTED INTO THE PATIENT, HOWEVER THE BROKEN FRAGMENTS OF THE SCREW HEAD WERE RETURNED TO LIMACORPORATE. THE VISUAL INSPECTION CONFIRMED THAT THE SCREW BROKE UNDER THE HEAD AND THAT THE HEAD ITSELF BROKE IN TWO HALVES. X-RAYS ANALYSIS POST-OPERATIVE X-RAYS WERE REQUESTED TO THE COMPLAINT SOURCE, BUT THEY WERE NOT AVAILABLE TO BE SHARED TO LIMACORPORATE. TEST PERFORMED TO FURTHER INVESTIGATE THE REPORTED INCIDENT, LIMACORPORATE DECIDED TO PERFORM THE ANALYSES ON SCREWS OF THE SPECIFIC LOT NUMBER INVOLVED AS WELL AS ON OTHER LOT NUMBERS OF THE SAME PRODUCT CODE (8420.15.040). SPECIFICALLY, THE FOLLOWING INVESTIGATIONS WERE PERFORMED: - DIMENSIONAL ANALYSIS TO CONFIRM THE ABSENCE OF DIMENSIONAL ANOMALIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED BREAKAGE - ANALYSIS ON THE TORSIONAL PROPERTIES OF THE SCREWS ACCORDING TO ASTM F543-17 - STANDARD SPECIFICATION AND TEST METHODS FOR METALLIC MEDICAL BONE SCREWS (THIS ANALYSIS WAS OUTSOURCED TO AN EXTERNAL LABORATORY) NINE SCREWS BELONGING TO PRODUCT CODE 8420.15.040 (35MM LENGTH), AVAILABLE IN INTERNAL WAREHOUSES, WERE THEREFORE USED FOR THE ANALYSES. AMONG THESE SCREWS, ONE BELONGS TO THE LOT NUMBER INVOLVED IN THIS COMPLAINT (2006390). DIMENSIONAL ANALYSIS: THE RELEVANT MEASURES OF ALL THE ABOVE-MENTIONED SCREWS WERE WITHIN THE EXPECTED TOLERANCES, NO DEVIATION WAS DETECTED. TORSIONAL PROPERTIES ANALYSIS: ALL THE BONE SCREWS WERE FOUND TO BE COMPLIANT TO THE MINIMUM ACCEPTABLE VALUES REPORTED ON ASTM F543-17: NO DEFORMATION NOR BREAKAGE APPEARED ON THE TESTED SCREWS. THE SCREWS RESISTED A TORQUE LOADING OF AT LEAST 6.2 NM AND A ROTATION ANGLE OF 90° WITH NO DEFORMATION NOR BREAKAGE. THE TORSIONAL STRENGTH ACCORDING TO ASTM F543-17 RESULTED (10.77 ± 0.46) NM. THE TORSIONAL ANALYSIS OF THE SCREWS WAS STOPPED AT THE MINIMAL REQUIREMENTS ACCORDING TO ASTM F543-17 AS TESTING UNTIL BREAKAGE COULD NOT HAVE BEEN COMPLETED DUE TO LIMITS OF THE SCREWDRIVERS (BREAKAGE/DEFORMATION). CONCLUSION AND PMS DATA BASED ON THE ANALYSES PERFORMED, WE CAN STATE THAT: - THE CHECK OF THE MANUFACTURING CHARTS HIGHLIGHTED NO PRE-EXISTING ANOMALIES ON THE TOTAL NUMBER OF SCREWS MANUFACTURED WITH LOT 2006390 - NO DIMENSIONAL ANOMALY WAS DETECTED ON THE SCREW THAT BELONG TO THE SAME LOT NUMBER (2006390) AVAILABLE AT INTERNAL WAREHOUSES - THE TORSIONAL PROPERTIES OF THE TESTED BONE SCREWS BELONGING TO CODE 8420.15.040 (INCLUDING ONE SCREW WITH LOT THE SAME LOT NUMBER OF THE ONE INVOLVED IN THIS COMPLAINT: 2006390) RESULTED COMPLIANT TO THE ASTM F543-17; THEREFORE, WE CANNOT DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE REPORTED BREAKAGE, HOWEVER WE SPECULATE THAT IT MIGHT BE RELATED TO THE INCORRECT APPLICATION OF LOAD TO THE SCREW ITSELF BY THE FINAL USER. IN DETAILS, IT IS POSSIBLE THAT A MISALIGNMENT OF THE SCREWDRIVER LED TO AN INCORRECT TRANSMISSION OF LOADS TO THE SCREW HEAD. THE HEAD OF THE SCREW GOT THEREFORE UNPROPERLY STRESSED BY A NON-AXIAL APPLICATION OF THE TORQUE, ULTIMATELY CAUSING ITS BREAKAGE. IN CONCLUSION, WE CLASSIFY THIS EVENT AS NOT PRODUCT RELATED. 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 < 0,001%. 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

    INTRA-OPERATIVE BREAKAGE OF THE HEAD OF THE SCREW WITH CODE 8420.15.040, LOT 2006390, STER. 2000206. THE SCREW REMAINED IMPLANTED. NO OTHER INFORMATION IS AVAILABLE AT THE MOMENT. THIS INCIDENT OCCURRED IN CROATIA.

    Description of Event or Problem · 0

    INTRA-OPERATIVE BREAKAGE OF THE HEAD OF THE BONE SCREW Ø6,5 H.35MM WITH CODE 8420.15.040, LOT 2006390, STER. 2000206. THE BREAKAGE OCCURRED DURING SHOULDER SURGERY WHILE IMPLANTING THE SCREW FOR THE FIXATION OF THE METAL BACK GLENOID. THE SCREW REMAINED IMPLANTED, WHILE THE BROKEN HEAD WAS REMOVED. NO DELAY TO COMPLETE THE SURGERY NOR OTHER CONSEQUENCES FOR THE PATIENT WERE REPORTED. THE COMPLAINT SOURCE REPORTED THAT THE INVOLVED SURGEON PERFORMED APROXIMATELY 50 SURGERIES IN LAST TWO YEARS USING THE SAME TECHNIQUE AND THAT THEY WERE UNSURE IF THE SURGEON APPLIED TOO MUCH FORCE WHILE SCREWING, MAYBE CONTRIBUTING TO THE BREAKAGE OCCURRED. THIS EVENT OCCURRED IN CROATIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277361 BONE SCREWS DIA. 6.5 X H. 35 MM BONE SCREWS DIA. 6.5 X H. 35 MM LPH LIMACORPORATE SPA 8420.15.040 2006390

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization