BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOABSORBABLE INTERFERENCE SCREWS

    MDR report key: 21430288 · Received February 21, 2025

    Report

    Report Number
    3004549189-2025-00002
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    December 2, 2024
    Report Date
    August 19, 2025
    Manufacturer
    S.B.M. SAS
    Product Code
    MAI
    PMA / PMN Number
    K122228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 2025. COMPLAINT RECEIVED ON JANUARY 06, 2025 - NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBER. THERE WERE NO PATIENT CONSEQUENCES REPORTED AND NO DELAY OVER THAN 30MN. VERIFICATION OF MANUFACTURING DATA: NO INCIDENTS DURING MANUFACTURING - THE RESULTS OF ONGOING CONTROLS ARE COMPLIANT. (B)(6) 2025: ANSWERS TO ADDITIONAL INFORMATION REQUESTS. . THE DESCRIPTION OF THE INCIDENT MENTIONS SEVERAL SCREWS: IS THERE MORE THAN ONE BROKEN SCREW? / ONLY ONE SCREW BROKEN · DID THE PATIENT RETAIN PIECES OF BROKEN SCREW? / YES · WHAT WAS THE DIAMETER OF THE TUNNEL? / 8MM · HAS A PRIOR TAPPING OF THE TUNNEL BEEN CARRIED OUT? / NO · WHAT WAS THE NATURE OF THE GRAFT (KJ, DT4, OTHER)? / NOT AWARE · PARTICULAR BONE QUALITY? / GOOD · DO YOU HAVE A PICTURE OF THE SCREW? / ALREADY SENT IMPLANTS TO CFA · WHAT WAS USED TO COMPLETE THE PROCEDURE (LOT NUMBER 230281) · IS THE SURGEON FAMILIAR WITH THIS MEDICAL DEVICE? / YES · WAS THIS HIS 1ST USE? BETWEEN 2 AND 10 POSES? / OR MORE THAN 10 POSES · DID THE HEALTH CARE FACILITY DECLARE THIS INCIDENT TO THE NATIONAL COMPETENT AUTHORITY? / NO REVISION OF DECLARABILITY ASSESSMENT FOLLOWING ADDITIONAL INFORMATION OF FEBRUARY 04, 2025: THE PATIENT RETAINED PIECE.S OF SCREW / POTENTIAL RISK OF MIGRATION. REQUEST TO RECOVER THE SCREW FOR EXPERTISE IF AVAILABLE - AWAITING FURTHER INFORMATION ON THE PIECE(S) OF SCREW LEFT IN THE PATIENT. (B)(6) 2025 RÉSULT OF ANALYSIS *MANUFACTURING DATA: BATCH 231294 COMPLIES WITH PRODUCTION REQUIREMENTS. *DIRECT ANALYSIS ON RETURNED DEVICE: THE SCREW HAS A TIP FRACTURE. IT MEASURES 22.9MM. THE FRACTURE ZONE WAS 2MM. THE BREAKAGE OF THE SCREW OCCURRED AT THE JUNCTION OF THE RECESS OF THE SCREWDRIVER WITH THE GUIDE ZONE OF THE GUIDE PIN. THE REMAINDER OF THE SCREW IS UNDAMAGED. OUTER DIAMETER: 9.9MM. GOOD VISIBILITY OF TCP GRANULES. 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, TWO POSSIBLE HYPOTHESES TO EXPLAIN THIS BREAKAGE ARE: 1. 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. FAILURE TO PRE-TAP THE TUNNEL USING THE APPROPRIATELY SIZED TAP INCREASES THE RISK OF THE SCREW BREAKING WHEN INSERTING IT INTO THE TUNNEL. 2. A TUNNEL DIAMETER SMALLER THAN THE SCREW DIAMETER GENERATED HIGH FRICTION FORCES OVER THE SURFACE OF THE SCREW WHEN PASSING THE CORTICAL WALL. IN THIS CASE, THE TUNNEL HAD A DIAMETER OF 8 MM FOR A 10 MM DIAMETER SCREW, AND THE ENTRANCE HAD NOT BEEN TAPPED. NON-COMPLIANCE WITH SURGICAL TECHNIQUE. NO CLINICAL CONSEQUENCE TO THE PATIENT - NO RISK OF MIGRATION OF THE PIECE OF THE DEVICE LEFT IN THE PATIENT. TO LIMIT SCREW BREAKAGE, A DOCUMENT REMINDING US HOW NOT TO BREAK A SCREW HAS BEEN SENT TO THE DISTRIBUTOR'S MARKETING DEPARTMENT IN (B)(6) 2024 TO SUPPORT SURGEON TRAINING, PARTICULARLY IN INDIA. THIS DOCUMENT WAS AGAIN SENT TO THE DISTRIBUTOR IN RESPONSE TO THE SCREW APPRAISAL, WITH A REMINDER OF THE IMPORTANCE OF APPLYING THE CORRECT OPERATING TECHNIQUE, IN PARTICULAR WITH REGARD TO THE DIAMETER OF THE TUNNEL IN RELATION TO THE DIAMETER OF THE SCREW USED.

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURED IN INDIA. COMPLAINT DESCRIPTION: ACL SCREWS ARE BROKEN DURING INSERTION OF SCREW IN TUNNEL SURGERY.

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURED IN INDIA. COMPLAINT DESCRIPTION: ACL SCREWS ARE BROKEN DURING INSERTION OF SCREW IN TUNNEL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1110365 BIOABSORBABLE INTERFERENCE SCREWS COMPOSITCP60 RESORBABLE INTERFERENCE SCREW - ROUND HEAD Ø10MM L25MM MAI S.B.M. SAS 231294

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Other