BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULLUP

    MDR report key: 16722190 · Received April 12, 2023

    Report

    Report Number
    3004549189-2023-00001
    Event Type
    Malfunction
    Date Received
    April 12, 2023
    Date of Event
    March 28, 2023
    Report Date
    October 23, 2023
    Manufacturer
    S.B.M. SAS
    Product Code
    MBI
    PMA / PMN Number
    K151004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DATE: APRIL 11, 2023. NO INCIDENT DURING MANUFACTURING - NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBER. WE LACK ELEMENT ON THE CIRCUMSTANCES OF THE INCIDENT: ADDITIONAL INFORMATION REQUESTED TO UNDERSTAND WHAT HAPPENED AND CONFIRMATION OF THE BATCH NUMBER AFFECTED BY THE BREAKAGE. ANALYSIS IS ONGOING: AWAITING RECOVERY OF THE BROKEN PRODUCT FOR EXPERTISE. DATE: OCTOBER 23, 2023 - FOLLOW UP1. RECOVERY OF 1 BOX LOT 231887 WITH 5 PADS MIXED IN A BAG AND 4 FOIL BAGS WITH BATCH NUMBERS - 3 LOT NUMBERS ARE CONCERNED (231887X1 ; 230462X2 ; 230467X2): NO OTHER COMPLAINTS. NO CLINICAL CONSEQUENCE - NO ADDITIONAL SURGERY - EXTENSION OF THE SURGERY BY MORE THAN 2 HOURS. THE SPECIFICATIONS OF THE 3 BATCHES ARE IN LINE WITH THE PRODUCTION REQUIREMENTS. THE DEVICES WERE RETURNED WITHOUT PULLUP BRAIDS, AND WITHOUT TRACTION WIRES FOR BATCHES 230462 AND 230467, AND WITHOUT PULLUP BRAID BUT WITH TRACTION WIRES FOR BATCH 231887. PULLUP BRAIDS ARE NOT AVAILABLE TO DETERMINE THE CAUSE OF BREAKAGE. ONLY ONE OF THE 4 PADS HAS SCRATCHES AT THE EDGE OF ONE OF THE 2 HOLES WHERE THE BRAID PASSES, BUT NOT THE OTHER 3 PADS. THESE SCRATCHES COULD HAVE BEEN CAUSED BY THE INSTRUMENT WHICH ALLOWED THE DEVICE TO BE DISMANTLED AFTER BREAKAGE. HYPOTHESIS NO. 1: EXCESSIVE TRACTION FORCE ON THE BRAIDS TO ADJUST THE LENGTH AND TENSION. HYPOTHESIS NO. 2: TILTING OF THE SPLICE IN ONE OF THE 2 HOLES IN THE PLATE, COMPRESSING THE SPLICE, AND NO LONGER ALLOWING THE LENGTH OF THE DEVICE TO BE ADJUSTED. THE EXPERTISE REPORT WAS TRANSMITTED TO OUR DISTRIBUTOR ON 23 OCTOBER 23.

    Additional Manufacturer Narrative · 0

    DATE: (B)(6) 2023. NO INCIDENT DURING MANUFACTURING - NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBER. WE LACK ELEMENT ON THE CIRCUMSTANCES OF THE INCIDENT: ADDITIONAL INFORMATION REQUESTED TO UNDERSTAND WHAT HAPPENED AND CONFIRMATION OF THE BATCH NUMBER AFFECTED BY THE BREAKAGE. ANALYSIS IS ONGOING: AWAITING RECOVERY OF THE BROKEN PRODUCT FOR EXPERTISE.

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURED IN VIETNAM: DESCRIPTION OF THE INCIDENT: "BROKEN CONTROLLED BLOCKING OF THE GRAFT". NO CLINICAL CONSEQUENCE - NO ADDITIONAL SURGERY - SURGICAL TIME WAS INCREASED OVER THAN 30 MN.

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURED IN VIETNAM: DESCRIPTION OF THE INCIDENT: "BROKEN CONTROLLED BLOCKING OF THE GRAFT." NO CLINICAL CONSEQUENCE - NO ADDITIONAL SURGERY - SURGICAL TIME WAS INCREASED OVER THAN 30 MN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211204 PULLUP PULLUP ADJUSTABLE FIXATION SYSTEM FOR LIGAMENT RECONSTRUCTION MBI S.B.M. SAS 230467

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Other