BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOABSORBABLE INTERFERENCE SCREWS

    MDR report key: 20039347 · Received August 22, 2024

    Report

    Report Number
    3004549189-2024-00005
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    June 26, 2024
    Report Date
    October 23, 2024
    Manufacturer
    S.B.M. SAS
    Product Code
    MAI
    PMA / PMN Number
    K122228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 2024 EXTRACTION OF BROKEN SCREW PIECES - USE OF ANOTHER SCREW TO COMPLETE THE SURGERY. VERIFICATION OF MANUFACTURING DOCUMENTS / OF: 3 BATCHES OF SCREWS ARE CONCERNED. LOT 221108 AND LOT 220785 SCREWS Ø7MM L25MM - CONFORM TO EXPECTED SPECIFICATIONS. LOT 220792 SCREW Ø9MM L25MM - CONFORMS TO EXPECTED SPECIFICATIONS. NO FURTHER COMPLAINTS CONCERNING THESE BATCHES. FOLLOWING THE RESPONSE TO THE ADDITIONAL INFORMATION REQUESTED, REASSESSMENT OF THE INCIDENT: DEEMED REPORTABLE - FORMALIZATION OF THE REPORT FOR REGULARIZATION. ADDITIONAL INFORMATION PROVIDED BY THE HEALTHCARE FACILITY AND DISTRIBUTOR: - IN WHAT ORDER WERE THE SCREWS USED? WHICH SCREW WAS IMPLANTED FIRST? Ø7 X2 THEN Ø9 - DID THE PATIENT KEEP ANY SCREW FRAGMENTS? YES, THE 2 FRAGMENTS OF SCREWS 7 - IF YES, CAN THESE SCREW FRAGMENTS MIGRATE? NO - HAS THE TUNNEL BEEN PRE-TAPPED? YES - IF YES, DIAMETER OF TUNNEL: 7/25 DIAMETER 10 SCREW IN FEMUR / 9/25 DIAMETER 10 SCREW IN TIBIA - PARTICULAR BONE QUALITY? YOUNG PATIENT - WHAT WAS THE NATURE OF THE GRAFT (KJ, DT4, OTHER)? KJ - DID THE EVENT DELAY SURGERY BY MORE THAN 30 MINUTES? YES - IF YES, CAN YOU EXPLAIN THE REASON FOR THE DELAY? SUCCESSIVE EXTRACTION OF FRAGMENTS - DO YOU HAVE PHOTOS OF THE BROKEN SCREWS? NO - IS THE SURGEON FAMILIAR WITH THE MEDICAL DEVICE? YES - WHAT IS THE NUMBER OF USES: BETWEEN 2 AND 10? OR DID HE DO MORE THAN 10 POSES? MORE THAN 10 POSES - WHAT BATCH NUMBER WAS USED TO COMPLETE THE PROCEDURE? 230218 DIAM 9 REQUEST FOR RECOVERY OF DEVICES FOR EXPERTISE: SCREWS SCRAPPED - NO PHOTOS. NO CORRECTIVE/PREVENTIVE ACTION TAKEN TO DATE. AWAITING INTERNAL INCIDENT ANALYSIS BASED ON INFORMATION PROVIDED. ____________________________________________________ 23 OCOTBER 2024 - FOLLOW UP1 INTERNAL ANALYSIS OF THE INCIDENT BASED ON THE INFORMATION PROVIDED AND PRODUCTION RECORDS. CONCERNING THE PRODUCTS USED: THE BATCHES COMPLY WITH EXPECTED PRODUCTION SPECIFICATIONS. 2 CROSS LIG® 55 RESORBABLE INTERFERENCE SCREWS - ROUND HEAD - RIGHT-HAND THREAD Ø 7 MM - L 25 MM - LOTS 220785 AND 221108. 1 CROSS LIG® 55 RESORBABLE INTERFERENCE SCREW - ROUND HEAD - RIGHT-HAND THREAD Ø 9 MM - L 25 MM - LOT 220792. GIVEN THE PROGRESS OF THE MANUFACTURING SESSION FOR THIS BATCH OF CROSS LIG, THE IMPLEMENTATION CONDITIONS CANNOT BE THE CAUSE OF THE FAILURE. THE HIGH LEVEL OF MOLECULAR MASS OF THESE BATCHES OF SCREWS ATTESTS TO THE VERY GOOD PROGRESS OF ITS MANUFACTURING. THE ABSENCE OF PRECISIONS OR PHOTOS OF THE SHAPE AND LOCATION OF THE FRACTURE OF THE SCREW DOES NOT ALLOW TO ESTABLISH THE TYPE OF RUPTURE. THE TWO DIAMETER 7MM SCREWS WERE IMPLANTED FIRST THEN THE SCREW DIAMETER 9MM L25. A PRIOR TAPPING OF THE TUNNEL WAS CARRIED OUT. CAUSE ROOT IDENTIFIED / HYPOTHESIS : WRONG CHOICE OF IMPLANT. CROSS LIG 55 SCREWS ARE RESERVED FOR USE WITH PURELY LIGAMENT GRAFTS (E.G. DT4). FOR A KJ GRAFT, A SCREW FROM THE CROSS LIG 30 RANGE SHOULD BE USED (ACCORDING TO THE CORRESPONDING SURGICAL TECHNIQUE).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024. EXTRACTION OF BROKEN SCREW PIECES - USE OF ANOTHER SCREW TO COMPLETE THE SURGERY. VERIFICATION OF MANUFACTURING DOCUMENTS / OF: 3 BATCHES OF SCREWS ARE CONCERNED. LOT 221108 AND LOT 220785 SCREWS Ø7MM L25MM - CONFORM TO EXPECTED SPECIFICATIONS. LOT 220792 SCREW Ø9MM L25MM - CONFORMS TO EXPECTED SPECIFICATIONS. NO FURTHER COMPLAINTS CONCERNING THESE BATCHES. FOLLOWING THE RESPONSE TO THE ADDITIONAL INFORMATION REQUESTED, REASSESSMENT OF THE INCIDENT: DEEMED REPORTABLE - FORMALIZATION OF THE REPORT FOR REGULARIZATION. ADDITIONAL INFORMATION PROVIDED BY THE HEALTHCARE FACILITY AND DISTRIBUTOR: IN WHAT ORDER WERE THE SCREWS USED? WHICH SCREW WAS IMPLANTED FIRST? Ø7 X2 THEN Ø9. DID THE PATIENT KEEP ANY SCREW FRAGMENTS? YES, THE 2 FRAGMENTS OF SCREWS 7. IF YES, CAN THESE SCREW FRAGMENTS MIGRATE? NO. HAS THE TUNNEL BEEN PRE-TAPPED? YES. IF YES, DIAMETER OF TUNNEL: 7/25 DIAMETER 10 SCREW IN FEMUR / 9/25 DIAMETER 10 SCREW IN TIBIA. PARTICULAR BONE QUALITY? YOUNG PATIENT. WHAT WAS THE NATURE OF THE GRAFT (KJ, DT4, OTHER)? KJ. DID THE EVENT DELAY SURGERY BY MORE THAN 30 MINUTES? YES. IF YES, CAN YOU EXPLAIN THE REASON FOR THE DELAY? SUCCESSIVE EXTRACTION OF FRAGMENTS DO YOU HAVE PHOTOS OF THE BROKEN SCREWS? NO. IS THE SURGEON FAMILIAR WITH THE MEDICAL DEVICE? YES. WHAT IS THE NUMBER OF USES: BETWEEN 2 AND 10? OR DID HE DO MORE THAN 10 POSES? MORE THAN 10 POSES. WHAT BATCH NUMBER WAS USED TO COMPLETE THE PROCEDURE? 230218 DIAM 9. REQUEST FOR RECOVERY OF DEVICES FOR EXPERTISE: SCREWS SCRAPPED - NO PHOTOS. NO CORRECTIVE/PREVENTIVE ACTION TAKEN TO DATE. AWAITING INTERNAL INCIDENT ANALYSIS BASED ON INFORMATION PROVIDED. ___________________________________________________

    Description of Event or Problem · 0

    FNCONF-24-0119 INCIDENT OCCURED IN FRENCH POLYNESIA. EVENT DESCRIPTION COMMUNICATED: "WHEN INSERTING THE SCREW, IT BROKE. THIS WAS REPEATED 3 TIMES, RESULTING IN 3 BROKEN INTERFERENCE SCREWS". NO CLINICAL CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURED IN FRENCH POLYNESIA. EVENT DESCRIPTION COMMUNICATED: "WHEN INSERTING THE SCREW, IT BROKE. THIS WAS REPEATED 3 TIMES, RESULTING IN 3 BROKEN INTERFERENCE SCREWS". NO CLINICAL CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29981 BIOABSORBABLE INTERFERENCE SCREWS CROSS LIG® 55 RESORBABLE INTERFERENCE SCREW - ROUND HEAD - Ø 7 MM - L 25 MM MAI S.B.M. SAS COM6007025 221108,220785

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Other