BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOABSORBABLE INTERFERENCE SCREWS

    MDR report key: 18424708 · Received January 2, 2024

    Report

    Report Number
    3004549189-2023-00006
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    September 6, 2023
    Report Date
    July 24, 2024
    Manufacturer
    S.B.M. SAS
    Product Code
    MAI
    PMA / PMN Number
    K122228
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    02 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. INSUFFICIENT INFORMATION / ADDITIONAL INFORMATION REQUESTED. 24 JULY 2024 - FOLLOW UP1 / CONCLUSION OF EXPERTISE. THE SCREW HAS A FRACTURED TIP. THE DAMAGED SCREW MEASURES 28.8MM. THE FRACTURE ZONE EXTENDS OVER 2.5MM. THE FRACTURE OCCURRED AT THE JUNCTION OF THE SCREWDRIVER CAVITY AND THE GUIDE PIN GUIDE ZONE. THE REMAINDER OF THE SCREW IS UNDAMAGED. OUTSIDE DIAMETER: 8.95MM. THE CAVITY STARTS 0.27MM BELOW THE HEAD: CHECK L PIN GUIDANCE ON SCREWS SCRAPPED AT THE START OF PRODUCTION: 3MM: PIN POSITIONING DURING INJECTION MOLD PREPARATION COMPLIES WITH OUR OPERATING MODE MOP-MT-033. CHECKING THE CAVITY WITH A Ø9 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. THE HIGH LEVEL OF MOLECULAR MASS OF THIS BATCH OF SCREWS ATTESTS TO THE VERY GOOD PROGRESS OF ITS MANUFACTURING. OBSERVATION OF THE SCREW REVEALS A COMBINED RUPTURE OF TWISTING AND PERFORATION AT THE BIRTH OF THE SCREWDRIVER RECESS. IN THE ABSENCE OF NUMEROUS ELEMENTS ON THE CIRCUMSTANCES OF THE SCREW BREAKAGE, THE HYPOTHESIS THAT COULD EXPLAIN THIS BREAKAGE IS AS FOLLOWS: DURING SCREWING, THE SCREW 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 SCREW TO BREAK. AGGRAVATING FACTOR: TUNNEL DIAMETER 8MM, INSUFFICIENT FOR A DIAMETER 9MM SCREW / NON-COMPLIANCE WITH SURGICAL TECHNIQUE. 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.

    Additional Manufacturer Narrative · 0

    (B)(6) 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. INSUFFICIENT INFORMATION / ADDITIONAL INFORMATION REQUESTED. ____________________________________________________

    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
    1227591 BIOABSORBABLE INTERFERENCE SCREWS LIGAFIX 60 RESORBABLE INTERFERENCE SCREW - ROUND HEAD Ø9MM L30MM MAI S.B.M. SAS 220179

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male Other