BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGIDLOOP

    MDR report key: 17744993 · Received September 14, 2023

    Report

    Report Number
    3004549189-2023-00002
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    August 29, 2023
    Report Date
    January 31, 2024
    Manufacturer
    S.B.M. SAS
    Product Code
    MBI
    PMA / PMN Number
    K202193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SEPTEMBER 12, 2023. NO PATIENT CONSEQUENCE. 3 BATCH NUMBERS CONCERNED: 217527 ; 222134 AND 222657. VERIFICATION OF MANUFACTURING DATA: NO INCIDENT. NO OTHER IDENTICAL COMPLAINTS REGARDING THE 3 BATCH NUMBERS. NO RECOVERY OF THE MEDICAL DEVICES FOR EXPERTISE: DISCARDED. WAITING FOR ADDITIONAL ELEMENT TO COMPLETE OUR INVESTIGATION. INSUFFICIENT INFORMATION / ANALYSIS IS ONGOING.

    Additional Manufacturer Narrative · 0

    SEPTEMBER 12, 2023. NO PATIENT CONSEQUENCE. 3 BATCH NUMBERS CONCERNED: 217527; 222134 AND 222657. VERIFICATION OF MANUFACTURING DATA: NO INCIDENT. NO OTHER IDENTICAL COMPLAINTS REGARDING THE 3 BATCH NUMBERS. NO RECOVERY OF THE MEDICAL DEVICES FOR EXPERTISE: DISCARDED. WAITING FOR ADDITIONAL ELEMENT TO COMPLETE OUR INVESTIGATION. INSUFFICIENT INFORMATION / ANALYSIS IS ONGOING. JANUARY 31, 2024. ALL 3 MEDICAL DEVICES WERE SCRAPPED - LACK OF PHOTOS OF THE PRODUCTS AND THEIR COMPONENTS THAT COULD HAVE ALLOWED US TO IDENTIFY THE CAUSE OF THE RUPTURE. SO, THE ORIGIN OF THE BREAKAGE OF THE SUTURE LOOPS TO BE SPLICED COULD NOT BE CLEARLY IDENTIFIED. THE MANUFACTURING DATA OF BATCHES 217527, 222134 AND 222657 COMPLY WITH THE REQUIRED REQUIREMENTS. LOT 217527: DATE OF MANUFACTURE: 2021-12-02 ; USE BEFORE 2026-12-01. CONFORMS TO EXPECTED SPECIFICATIONS. LOT 222134: DATE OF MANUFACTURE: 2022-06-02 ; USE BEFORE 2027-06-01. CONFORMS TO EXPECTED SPECIFICATIONS. LOT 222657: DATE OF MANUFACTURE: 2022-07-02 ; USE BEFORE 2027-07-01. CONFORMS TO EXPECTED SPECIFICATIONS. ROOT CAUSE / HYPOTHESIS: HYPOTHESIS NO. 1: FAULT NOT DETECTED ON THE BLACK WIRES WHICH HAVE BROKEN. HYPOTHESIS NO. 2: LACK OF PRACTICE / USER TRAINING. SINCE 2019, THE FOLLOWING ACTIONS HAVE MADE IT POSSIBLE TO LIMIT THE RISK OF RUPTURE OF THE SUTURE LOOP TO BE SPLICED: RAISING OPERATOR AWARENESS OF THE PRECAUTIONS TO BE TAKEN WHEN ASSEMBLING THE SUTURES TO BE SPLICED ONTO THE PULTRESSE2 BRAID. ADDITION OF THE PHASE OF CONTROLLING THE SUTURE LOOPS TO BE SPLICED AFTER ASSEMBLY ON THE PULTRESSE2 BRAID ON THE PRODUCTION DOCUMENTS (PROCEDURE FOR ASSEMBLING THE PULLUP SYSTEM ; PACKAGING CONTROL SHEET). FURTHERMORE, THE INTERNALIZATION OF THE BRAIDING PROCESS HAS MADE IT POSSIBLE TO SIGNIFICANTLY REDUCE THE EFFORT REQUIRED TO MAKE THE SPLICES. NO ACTION IMPLEMENTED. THE COMPLAINT IS CLOSED.

    Description of Event or Problem · 0

    FNCONF-23-0132. INCIDENT OCCURED IN UNITED STATES: INFORMATION TRANSMITTED BY OUR DISTRIBUTOR: WE RECEIVED A S.B.M. SAS PRODUCT COMPLAINT WITH THE FOLLOWING EVENT DESCRIPTION AS REPORTED TO DEPUY MITEK ON (B)(6). EVENT DATE WAS (B)(6) FOR ONE RGDLOOP BTB ADJ BUTTON PRODUCT CODE 232485 WITH LOT NUMBER 217527, ONE RGDLOOP BTB ADJ BUTTON PRODUCT CODE 232485 WITH LOT NUMBER 222134 AND ONE RGDLOOP BTB ADJ BUTTON PRODUCT CODE 232485 WITH LOT NUMBER UNKNOWN. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION, WERE DISCARDED. ATTACHED IS THE COMPLAINT DETAIL REPORT. EVENT DESCRIPTION: DURING AN ACL CASE, THREE BTB BUTTONS REF# 232485 HAD FAILURES WITH THE SUTURE RELAY LOOPS. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> YES, IF YES, NUMBER OF MINUTES: --> 30, ACTION TAKEN WHEN EVENT OCCURRED? --> REPLACED BUTTON., WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? --> UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN.

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURED IN UNITED STATES: INFORMATION TRANSMITTED BY OUR DISTRIBUTOR: WE RECEIVED A S.B.M. SAS PRODUCT COMPLAINT WITH THE FOLLOWING EVENT DESCRIPTION AS REPORTED TO DEPUY MITEK ON AUGUST 29TH. EVENT DATE WAS AUGUST 29TH FOR ONE RGDLOOP BTB ADJ BUTTON PRODUCT CODE 232485 WITH LOT NUMBER 217527, ONE RGDLOOP BTB ADJ BUTTON PRODUCT CODE 232485 WITH LOT NUMBER 222134 AND ONE RGDLOOP BTB ADJ BUTTON PRODUCT CODE 232485 WITH LOT NUMBER UNKNOWN. THE DEVICES ARE NOT AVAILABLE FOR EVALUATION, WERE DISCARDED. ATTACHED IS THE COMPLAINT DETAIL REPORT. EVENT DESCRIPTION: DURING AN ACL CASE, THREE BTB BUTTONS REF# 232485 HAD FAILURES WITH THE SUTURE RELAY LOOPS. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? - YES, IF YES, NUMBER OF MINUTES: -- 30, ACTION TAKEN WHEN EVENT OCCURRED? - REPLACED BUTTON., WAS PROCEDURE SUCCESSFULLY COMPLETED? -- YES, WERE FRAGMENTS GENERATED? - NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? -- UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES - NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: - UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY - UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2225787 RIGIDLOOP RIGIDLOOP BTB ADJUSTABLE CORTICAL SYSTEM - STANDARD MBI S.B.M. SAS 217527

    Patients

    Seq Age Sex Outcome Treatment
    1 00 YR Unknown Other