BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESORBABLE INTERFERENCE SCREW

    MDR report key: 22050445 · Received May 20, 2025

    Report

    Report Number
    3004549189-2025-00009
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    January 3, 2024
    Report Date
    August 12, 2025
    Manufacturer
    S.B.M. SAS
    Product Code
    MAI
    PMA / PMN Number
    K122228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    20 MAY 2025 VERIFICATION OF MANUFACTURING DATA: NO INCIDENTS DURING MANUFACTURING. CONTROL RESULTS COMPLY WITH EXPECTED SPECIFICATIONS. NO OTHER COMPLAINT CONCERNING THIS BATCH. ADDITIONAL INFORMATION REQUESTED: AFTER ANALYZING THE HISTORY OF THE INCIDENT, I NOTE THAT THE INTERVENTION CONCERNING THE REMOVAL OF THE SCREW WAS CARRIED OUT IN (B)(6) 2024 AND YOUR CLAIM / DECLARATION DATES FROM (B)(6) 2025. WHY IS THERE SUCH A GAP IN TIME? IN THE SBM INCIDENT REPORT, YOU MENTION A TEMPORARY ANSM FILE NUMBER (B)(4): DID YOU RECEIVE A REGISTRATION FILE NUMBER FROM THE ANSM? IF SO, WHICH ONE? 2 LIGAFIX SCREWS ARE CONCERNED IN THE DESCRIPTION. IF POSSIBLE, CAN YOU TELL ME THE BATCH OF THE SCREW THAT WAS REMOVED AND THAT CAUSED THE PAIN? THE PATIENT RETAINED A PIECE OF DM": IS THIS PART OF THE SCREW REMOVED? IF NOT, IS IT THE 2ND SCREW? WHAT WERE THE TUNNEL DIAMETERS FOR EACH OF THE SCREWS IMPLANTED DURING THE INITIAL SURGERY (LOT 221187 Ø9MM L25MM AND LOT 221790 Ø8MM AND L25MM). WHAT WAS THE NATURE OF THE GRAFT / INITIAL SURGERY (KJ, DT4, OTHER)? THESE SCREWS ARE RESORBABLE OVER TIME: HAVE THERE BEEN ANY FOLLOW-UP EXAMINATIONS BETWEEN THE DATE OF HIS SURGERY (B)(6) 2022) AND THE DATE OF THE PAIN DESCRIPTION (B)(6) 2023) THAT WOULD SHOW THE EVOLUTION OF THIS RESORPTION? INVESTIGATIONS IN PROGRESS - NO CORRECTIVE/PREVENTIVE ACTIONS. ____________________________________________________

    Additional Manufacturer Narrative · 0

    20 MAY 2025 VERIFICATION OF MANUFACTURING DATA: NO INCIDENTS DURING MANUFACTURING. CONTROL RESULTS COMPLY WITH EXPECTED SPECIFICATIONS. NO OTHER COMPLAINT CONCERNING THIS BATCH. ADDITIONAL INFORMATION REQUESTED: *AFTER ANALYZING THE HISTORY OF THE INCIDENT, I NOTE THAT THE INTERVENTION CONCERNING THE REMOVAL OF THE SCREW WAS CARRIED OUT IN (B)(6) 2024 AND YOUR CLAIM / DECLARATION DATES FROM MAY 2025. WHY IS THERE SUCH A GAP IN TIME? *IN THE SBM INCIDENT REPORT, YOU MENTION A TEMPORARY ANSM FILE NUMBER (20250505113921840): DID YOU RECEIVE A REGISTRATION FILE NUMBER FROM THE ANSM? IF SO, WHICH ONE? *2 LIGAFIX SCREWS ARE CONCERNED IN THE DESCRIPTION. IF POSSIBLE, CAN YOU TELL ME THE BATCH OF THE SCREW THAT WAS REMOVED AND THAT CAUSED THE PAIN? *THE PATIENT RETAINED A PIECE OF DM": IS THIS PART OF THE SCREW REMOVED? IF NOT, IS IT THE 2ND SCREW? *WHAT WERE THE TUNNEL DIAMETERS FOR EACH OF THE SCREWS IMPLANTED DURING THE INITIAL SURGERY (LOT 221187 Ø9MM L25MM AND LOT 221790 Ø8MM AND L25MM). *WHAT WAS THE NATURE OF THE GRAFT / INITIAL SURGERY (KJ, DT4, OTHER)? *THESE SCREWS ARE RESORBABLE OVER TIME: HAVE THERE BEEN ANY FOLLOW-UP EXAMINATIONS BETWEEN THE DATE OF HIS SURGERY (B)(6) 2022) AND THE DATE OF THE PAIN DESCRIPTION (APRIL 2023) THAT WOULD SHOW THE EVOLUTION OF THIS RESORPTION? INVESTIGATIONS IN PROGRESS - NO CORRECTIVE/PREVENTIVE ACTIONS. ____________________________________________________ 12 AUGUST 2025 RESULT OF EXPERTISE REPORT. THE INCIDENT WAS ASSESSED BASED ON THE INFORMATION AND DOCUMENTS PROVIDED. NO DEVICES WERE RECOVERED. ANALYSIS RESULTS: VERIFICATION OF MANUFACTURING DATA FOR THE TWO LIGAFIX SCREWS USED: THE BATCHES COMPLY WITH THE EXPECTED SPECIFICATIONS. THE EXTRACT FROM THE INTERVENTION REPORT MENTIONS THE USE OF COMPETING DEVICES, "BIOSURE HA SCREW" AND NOT LIGAFIX. GIVEN THE BATCHES AND REFERENCES PROVIDED FOR THE TRACEABILITY OF THE DEVICES IMPLANTED IN THE PATIENT, WE CONSIDER THAT THE NAMES MENTIONED IN THE REPORT ARE INCORRECT AND THAT THE DEVICES ACTUALLY IMPLANTED ARE LIGAFIX SCREWS. FURTHERMORE, THE BATCHES AND REFERENCES PROVIDED CORRESPOND TO THE SIZE OF THE SCREWS IMPLANTED, WHICH ARE SPECIFIED IN THE SURGICAL REPORT. LIGAFIX SCREWS WERE USED FOR DI-DT LIGAMENTOPLASTY, EXCEPT THAT THE LOCATION OF THE PAIN IS AT THE GERDY TUBERCLE, WHICH CORRESPONDS TO THE LOCATION OF THE Ø4.75 SCREW. THE LIGAFIX DEVICES ARE THEREFORE NOT THE CAUSE OF THE PAIN IN THIS AREA, BUT RATHER THE BIOSURE HA SCREW Ø4.75 USED TO FIX THE ANTEROLATERAL PLASTY TRANSPLANT. THIS SCREW IS NOT MANUFACTURED BY SBM / NO FURTHER INVESTIGATION. NO ACTION IMPLEMENTED.

    Description of Event or Problem · 0

    FNCONF(B)(4) INCIDENT OCCURED IN FRANCE. DESCRIPTION OF INCIDENT: PATIENT AGED 17 AT THE TIME OF THE INCIDENT, TREATED FOR RIGHT KNEE CRUCIATE LIGAMENT SURGERY, DATE OF SURGERY (B)(6) 2022. ON (B)(6) 2023 DESCRIPTION OF PAIN: "THE EXTERNAL TIBIAL RETURN INSERTION DOES INDEED CAUSE THE PAIN YOU REPORT TO ME WHEN RUNNING". INFILTRATION PERFORMED IN (B)(6) 2023. ON (B)(6) 2023 SUSPECTED SCREW PROTRUSION ON GERDY TUBERCLE, CONFIRMED ON MRI (B)(6) 2023. ON (B)(6) 2024 INTERVENTION TO REMOVE SCREW. MEDICAL DEVICES IMPLANTED ON (B)(6) 2022: TENDON ANCHORING SYSTEM: FIBERLOOP O LOOP RIGHT NEEDLE / ARTHREX FRANCE. INTERFERENCE SCREW LIGAFIX30 COM3009025 Ø9MM L25MM LOT 221187 / S.B.M. SAS. INTERFERENCE SCREW LIGAFIX30 COM3008025 Ø8MM L25MM LOT 221790 / S.B.M. SAS. DECLARATION OF THE INCIDENT TO ANSM / FRANCE BY THE HEALTHCARE ESTABLISHMENT.

    Description of Event or Problem · 0

    FNCONF-25-0089 INCIDENT OCCURED IN FRANCE. DESCRIPTION OF INCIDENT: PATIENT AGED 17 AT THE TIME OF THE INCIDENT, TREATED FOR RIGHT KNEE CRUCIATE LIGAMENT SURGERY, DATE OF SURGERY (B)(6) 2022. ON (B)(6) 2023 DESCRIPTION OF PAIN: "THE EXTERNAL TIBIAL RETURN INSERTION DOES INDEED CAUSE THE PAIN YOU REPORT TO ME WHEN RUNNING". INFILTRATION PERFORMED IN (B)(6) 2023. ON (B)(6) 2023 SUSPECTED SCREW PROTRUSION ON GERDY TUBERCLE, CONFIRMED ON MRI (B)(6) 2023. ON (B)(6) 2024 INTERVENTION TO REMOVE SCREW. MEDICAL DEVICES IMPLANTED ON (B)(6) 2022: TENDON ANCHORING SYSTEM: FIBERLOOP O LOOP RIGHT NEEDLE / ARTHREX FRANCE INTERFERENCE SCREW LIGAFIX30 COM3009025 Ø9MM L25MM LOT 221187 / S.B.M. SAS. INTERFERENCE SCREW LIGAFIX30 COM3008025 Ø8MM L25MM LOT 221790 / S.B.M. SAS. DECLARATION OF THE INCIDENT TO ANSM / FRANCE BY THE HEALTHCARE ESTABLISHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2128940 RESORBABLE INTERFERENCE SCREW LIGAFIX® 30 RESORBABLE INTERFERENCE SCREW - ROUND HEAD Ø 9 MM - L 25 MM MAI S.B.M. SAS 221187

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female Other