BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGIDLOOP

    MDR report key: 18036930 · Received October 31, 2023

    Report

    Report Number
    3004549189-2023-00004
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    October 11, 2023
    Report Date
    July 22, 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

    (B)(6) 2023. DATE OF EVENT AND BATCH NUMBER NOT COMMUNICATED: VERIFICATION OF PENDING MANUFACTURING DATA. THERE WAS A DELAY IN SURGERY OF 45MN - NO CONSEQUENCE OR IMPACT TO PATIENT STIPULATED. ADDITIONAL INFORMATION REQUESTED TO COMPLETE OUR INVESTIGATION: IF THE INFORMATION AVAILABLE, HAD THE RIGIDLOOP SPLICE "TURNED" ON THE BRIDGE OF THE BUTTON? HOW WAS THE GRAFT ATTACHED TO THE TIBIA? IS THE SURGEON FAMILIAR WITH THE MEDICAL DEVICE? HOW WAS THE SURGEON TRAINED TO USE THE RIGIDLOOP BTB DEVICE? DATE OF THE EVENT? LOT NUMBER? PRODUCT IS DISCARDED: IMAGE AVAILABLE FOR ASSESSMENT? DID THE HEALTH CARE FACILITY DECLARE THIS INCIDENT TO THE NATIONAL COMPETENT AUTHORITY / SWISSMEDIC? IF YES, WHAT IS THE FILE NUMBER? IS IT POSSIBLE TO HAVE A COPY OF THIS DECLARATION? WAITING FOR ADDITIONAL ELEMENT TO COMPLETE OUR INVESTIGATION. INSUFFICIENT INFORMATION / ANALYSIS IS ONGOING.

    Additional Manufacturer Narrative · 0

    30 OCTOBER 2023. DATE OF EVENT AND BATCH NUMBER NOT COMMUNICATED: VERIFICATION OF PENDING MANUFACTURING DATA. THERE WAS A DELAY IN SURGERY OF 45MN - NO CONSEQUENCE OR IMPACT TO PATIENT STIPULATED. ADDITIONAL INFORMATION REQUESTED TO COMPLETE OUR INVESTIGATION: IF THE INFORMATION AVAILABLE, HAD THE RIGIDLOOP SPLICE "TURNED" ON THE BRIDGE OF THE BUTTON? HOW WAS THE GRAFT ATTACHED TO THE TIBIA? IS THE SURGEON FAMILIAR WITH THE MEDICAL DEVICE? HOW WAS THE SURGEON TRAINED TO USE THE RIGIDLOOP BTB DEVICE? DATE OF THE EVENT? LOT NUMBER? PRODUCT IS DISCARDED: IMAGE AVAILABLE FOR ASSESSMENT? DID THE HEALTH CARE FACILITY DECLARE THIS INCIDENT TO THE NATIONAL COMPETENT AUTHORITY / SWISSMEDIC? IF YES, WHAT IS THE FILE NUMBER? IS IT POSSIBLE TO HAVE A COPY OF THIS DECLARATION? WAITING FOR ADDITIONAL ELEMENT TO COMPLETE OUR INVESTIGATION. INSUFFICIENT INFORMATION / ANALYSIS IS ONGOING. 22 JULY 2024 - FOLLOW UP1 / ANALYSIS OF THE INCIDENT ACCORDING TO THE INFORMATION TRANSMITTED - BATCH NUMBER NOT COMMUNICATED. ADDITIONAL INFORMATION REQUESTED TO COMPLETE OUR INVESTIGATION: IF THE INFORMATION AVAILABLE, HAD THE RIGIDLOOP SPLICE "TURNED" ON THE BRIDGE OF THE BUTTON? NO HOW WAS THE GRAFT ATTACHED TO THE TIBIA? WITH 2X FIBERLOOP AND 1X SPEEDTRAP IS THE SURGEON FAMILIAR WITH THE MEDICAL DEVICE? TRAINED IN CAB LAB, BUT FIRST SURGERY HOW WAS THE SURGEON TRAINED TO USE THE RIGIDLOOP BTB DEVICE? TRAINED IN CAB LAB DATE OF THE EVENT? 11TH OCTOBER 2023. LOT NUMBER? (NOT COMMUNICATED). PRODUCT IS DISCARDED: IMAGE AVAILABLE FOR ASSESSMENT? NO. DID THE HEALTH CARE FACILITY DECLARE THIS INCIDENT TO THE NATIONAL COMPETENT AUTHORITY / SWISSMEDIC? NO. IF YES, WHAT IS THE FILE NUMBER? IS IT POSSIBLE TO HAVE A COPY OF THIS DECLARATION? NO. THE BONE ROD HAD DIFFICULTY PROGRESSING INTO THE FEMORAL TUNNEL - THE ALTERNATING TRACTION OF THE 2 BRAIDS ON THE BONE ROD WORE OUT THE BRAIDS, WHICH BROKE. THE BROKEN DM WAS REPLACED BY ANOTHER RIGIDLOOP BTB. THE DEVICE WAS SCRAPPED - THERE WERE NO PHOTOS OF THE DEVICE AND ITS COMPONENTS TO IDENTIFY THE EXACT CAUSE OF THE BREAKAGE. THE ORIGIN OF THE LOOP BREAKAGES APPEARS TO RESULT FROM A VERY SIGNIFICANT TRACTION FORCE WHEN ENGAGING THE SECOND HALF OF THE BONE ROD IN THE FEMORAL TUNNEL AND FROM FRICTION IN THE GRAFT HOLES AT THE CORTICAL LEVEL - THE GRAFT WAS FINALLY PLACED BY INSERTING THE BONE ROD ON THE TIBIA SIDE (PROBABLY WIDER TUNNEL) WITH A NEW RIGIDLOOP BTB IMPLANT. HYPOTHESIS NO. 1: BONE ROD TOO LARGE, BONE CHIPS AT THE EDGE OF THE HOLES DRILLED IN THE GRAFT OR AT THE EDGE OF THE TUNNEL. HYPOTHESIS NO. 2: LACK OF PRACTICE / USER TRAINING (FIRST SURGERY). NO ACTION IMPLEMENTED - EXPERTISE REPORT TRANSMITTED TO OUR DISTRIBUTOR.

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURED IN SWITZERLAND: OUR DISTRIBUTOR RECEIVED A S.B.M. SAS PRODUCT COMPLAINT WITH THE FOLLOWING EVENT DESCRIPTION AS REPORTED TO IT ON OCTOBER 12TH. EVENT DATE WAS UNKNOWN FOR ONE RGDLOOP BTB ADJ BUTTON PRODUCT CODE 232485 WITH LOT NUMBER UNKNOWN. THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. IT WAS DISCARDED. EVENT DESCRIPTION: THE RIGIDLOOP BTB BUTTON WAS USED FOR A REVISION ACL SURGERY. AFTER THE BUTTON WAS FLIPPED ON THE FEMORAL CORTEX, THE WHITE TENSIONING SUTURES WERE PULLED TO ADVANCE THE BONE PLUG INTO THE FEMORAL SOCKET. HALF OF THE BONE PLUG WAS ALREADY IN THE TUNNEL, WHILE THE OTHER HALF DID NOT ADVANCE EASILY. BY ALTERNATIVELY PULLING THE TWO WHITE SUTURES, THEY HAVE WORN THEMSELVES OUT ON THE BONE PLUG AND BROKE. THE WHOLE SYSTEM HAD TO BE REMOVED AND A RIGIDLOOP ADJUSTABLE WAS USED AS A REPLACEMENT OPTION, WITH THE BONE PLUG FIXATED IN THE TIBIA INSTEAD OF THE FEMUR. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES IF YES, NUMBER OF MINUTES: 45. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. WAS OTHER MEDICAL INTERVENTION UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN.

    Description of Event or Problem · 0

    FNCONF-23-0150. INCIDENT OCCURED IN SWITZERLAND: OUR DISTRIBUTOR RECEIVED A S.B.M. SAS PRODUCT COMPLAINT WITH THE FOLLOWING EVENT DESCRIPTION AS REPORTED TO IT ON OCTOBER 12TH. EVENT DATE WAS UNKNOWN FOR ONE RGDLOOP BTB ADJ BUTTON PRODUCT CODE 232485 WITH LOT NUMBER UNKNOWN. THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. IT WAS DISCARDED. EVENT DESCRIPTION: THE RIGIDLOOP BTB BUTTON WAS USED FOR A REVISION ACL SURGERY. AFTER THE BUTTON WAS FLIPPED ON THE FEMORAL CORTEX, THE WHITE TENSIONING SUTURES WERE PULLED TO ADVANCE THE BONE PLUG INTO THE FEMORAL SOCKET. HALF OF THE BONE PLUG WAS ALREADY IN THE TUNNEL, WHILE THE OTHER HALF DID NOT ADVANCE EASILY. BY ALTERNATIVELY PULLING THE TWO WHITE SUTURES, THEY HAVE WORN THEMSELVES OUT ON THE BONE PLUG AND BROKE. THE WHOLE SYSTEM HAD TO BE REMOVED AND A RIGIDLOOP ADJUSTABLE WAS USED AS A REPLACEMENT OPTION, WITH THE BONE PLUG FIXATED IN THE TIBIA INSTEAD OF THE FEMUR. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 45. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. WAS OTHER MEDICAL INTERVENTION UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2226598 RIGIDLOOP RIGIDLOOP BTB ADJUSTABLE CORTICAL SYSTEM - STANDARD MBI S.B.M. SAS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Other