BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOABSORBABLE INTERFERENCE SCREWS

    MDR report key: 18434269 · Received January 3, 2024

    Report

    Report Number
    3004549189-2023-00007
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    September 19, 2023
    Report Date
    July 25, 2024
    Manufacturer
    S.B.M. SAS
    Product Code
    MAI
    PMA / PMN Number
    K122228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    03 JANUARY 2024 NO CLINICAL CONSEQUENCE - NO ADDITIONAL SURGERY - THE PATIENT DID NOT RETAIN ANY PIECES OF SCREW - SURGICAL TIME WAS INCREASED OVER THAN 30 MN RELATED TO THIS EVENT. NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBER - NO INCIDENT DURING MANUFACTURING. WAITING FOR ADDITIONAL INFORMATION TO COMPLETE OUR INVESTIGATION. A SECOND LIGAFIX 60 SCREW Ø 8MM L 25MM LOT 220262 WAS USED AND BROKE TOO. INSUFFICIENT INFORMATION / ADDITIONAL INFORMATION REQUESTED. ____________________________________________________

    Additional Manufacturer Narrative · 0

    03 JANUARY 2024: NO CLINICAL CONSEQUENCE - NO ADDITIONAL SURGERY - THE PATIENT DID NOT RETAIN ANY PIECES OF SCREW - SURGICAL TIME WAS INCREASED OVER THAN 30 MN RELATED TO THIS EVENT. NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBER - NO INCIDENT DURING MANUFACTURING. WAITING FOR ADDITIONAL INFORMATION TO COMPLETE OUR INVESTIGATION. A SECOND LIGAFIX 60 SCREW Ø 8MM L 25MM LOT 220262 WAS USED AND BROKE TOO. INSUFFICIENT INFORMATION / ADDITIONAL INFORMATION REQUESTED. 25 JULY - FOLLOW UP1 / CONCLUSION OF EXPERTISE. 2 SCREWS HAVE BEEN RETURNED. LOT 221875 Ø9MM L30MM: THE SCREW HAS A FRACTURED TIP. THE DAMAGED SCREW MEASURES 27.9MM. THE FRACTURE ZONE EXTENDS OVER 3.1MM. THE FRACTURE OCCURRED AT THE JUNCTION OF THE SCREWDRIVER CAVITY AND THE GUIDE PIN GUIDE ZONE. THE REST OF THE SCREW IS UNDAMAGED. OUTSIDE DIAMETER: 8.97MM: THE CAVITY STARTS 0.16MM BELOW THE HEAD => CHECK PIN GUIDE LENGTH ON SCRAP SCREWS AT THE START OF PRODUCTION: 3MM => PIN POSITIONING DURING INJECTION MOLD PREPARATION COMPLIES WITH OUR MOP-MT-033 PREPARATION OF THE LIGAFIX INJECTION MOLD. CHECKING THE CAVITY WITH A 9MM DIAMETER SCREWDRIVER (LOT 130671): THE SCREWDRIVER EASILY PENETRATES THE CAVITY AND COMES TO REST AT THE BOTTOM OF THE CAVITY. EXCELLENT VISIBILITY OF TCP GRANULES. THIS BATCH OF SCREWS DOES NOT PRESENT ANY MANUFACTURING ANOMALIES. EVERYTHING IS CONSISTENT. GIVEN THE PROGRESS OF THE MANUFACTURING SESSION FOR THIS BATCH OF LIGAFIX, THE IMPLEMENTATION CONDITIONS CANNOT BE THE CAUSE OF THE FAILURE. LOT 220262 Ø8MM L25MM: THE SCREW IS FRACTURED INTO TWO PIECES. LENGTH OF THE PIECE CONTAINING THE SCREW HEAD: MIN. 15.97MM / MAX. 21.98MM. THE PIECE CONTAINING THE TIP IS MISSING. THE FRACTURE OCCURRED IN THE FIRST THIRD OF THE LENGTH. THE THREADS ARE UNDAMAGED, EXCEPT FOR THE ONE CLOSEST TO THE SCREW TIP. THE SCREWDRIVER'S IMPRESSION SHOWS NO DAMAGE TO THE PIECE OF SCREW RECOVERED. A Ø8MM SCREWDRIVER WILL NOT COME TO REST AT THE BOTTOM OF THE SCREW CAVITY IN THE ABSENCE OF THE TIP: TEST CARRIED OUT WITH A LIGAFIX Ø8MM SCREWDRIVER LOT 110113. TISSUE RESIDUES ARE PRESENT AT THE FRACTURE SITE. TCP GRANULES ARE CLEARLY VISIBLE. THIS BATCH OF SCREWS DOES NOT PRESENT ANY MANUFACTURING ANOMALIES. EVERYTHING IS CONSISTENT. GIVEN THE PROGRESS OF THE MANUFACTURING SESSION FOR THIS BATCH OF LIGAFIX, THE IMPLEMENTATION CONDITIONS CANNOT BE THE CAUSE OF THE FAILURE. LOT 221875 Ø9MM L30MM AND LOT 220262 Ø8MM L25MM: IN THE ABSENCE OF NUMEROUS ELEMENTS ON THE CIRCUMSTANCES OF THE SCREW BREAKAGES, THE HYPOTHESIS PUT FORWARD FOR THESE BREAKAGES IS AS FOLLOWS: DURING SCREWING, THE SCREWS PRODUCED A DIVERGENT TRAJECTORY IN THE TUNNEL, CAUSING SIGNIFICANT STRESSES IN BENDING AND TORSION UP TO THE CORE OF THE SCREW, PARTICULARLY WHEN PASSING THE CORTICAL WALL. THESE CONSTRAINTS CAUSED A DEFORMATION OF THE SCREWDRIVER RECESS, WHICH IS ALMOST ZERO AT THE END OF THE SCREWDRIVER RECESS AND MAXIMUM AT THE LEVEL OF THE SCREW HEAD. THE DEFORMATION OF THE SCREWDRIVER IS THEN GREATER THAN THE ELASTIC LIMIT OF THE DUOSORB, CAUSING THE SCREWS TO BREAK. AGGRAVATING FACTOR: TUNNEL DIAMETER 8MM, INSUFFICIENT FOR A SCREW DIAMETER 9MM (NO RESPECT OF OPERATIVE TECHNIQUE). IN EFFECT, A TUNNEL DIAMETER SMALLER THAN THE SCREW DIAMETER GENERATED HIGH FRICTION FORCES ACROSS THE ENTIRE SURFACE OF THE SCREW AS IT PASSED THROUGH THE CORTICAL WALL. EXPERTISE REPORT SENT TO THE DISTRIBUTOR WITH REMINDER OF THE IMPORTANCE OF ADHERING TO THE OPERATING TECHNIQUE, PARTICULARLY WITH REGARD TO THE DIAMETER OF THE TUNNEL IN RELATION TO THE DIAMETER OF THE SCREW USED. NO ACTION IMPLEMENTED.

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURED IN MALAYSIA: EVENT DESCRIPTION COMMUNICATED. "SCREW BROKE AT THE TIP WHILE SURGEON ATTEMPTING TO SCREW INTO THE TUNNEL".

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURED IN MALAYSIA: EVENT DESCRIPTION COMMUNICATED. "SCREW BROKE AT THE TIP WHILE SURGEON ATTEMPTING TO SCREW INTO THE TUNNEL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506577 BIOABSORBABLE INTERFERENCE SCREWS LIGAFIX 60 RESORBABLE INTERFERENCE SCREW - ROUND HEAD Ø9MM L30MM MAI S.B.M. SAS 221875

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male Other