BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-LOC 90

    MDR report key: 21229803 · Received January 24, 2025

    Report

    Report Number
    1219930-2025-00430
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    January 8, 2025
    Report Date
    February 13, 2025
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    UDI-DI
    10884521132276
    PMA / PMN Number
    K100257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT MEDICAL PRODUCT: VLOCM0134, VLOCM0134 V-LOC* 90 3-0 CLR 58CM P14X12 (LOT#A3J2064VFY); VLOCM0134, VLOCM0134 V-LOC* 90 3-0 CLR 58CM P14X12 (LOT#A3J2064VFY); VLOCM0134, VLOCM0134 V-LOC* 90 3-0 CLR 58CM P14X12 (LOT#A3J2064VFY) MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING A BILATERAL TOTAL KNEE REPLACEMENT, WHILE SUTURING, THE MIDDLE OF THE SUTURE BROKE. IT WAS NOTED THAT FOUR SUTURES HAD THE SAME ISSUE. THE SURGICAL TIME WAS EXTENDED BY FIFTEEN MINUTES. THE USER REPLACED THE DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING A BILATERAL TOTAL KNEE REPLACEMENT, WHILE SUTURING, THE MIDDLE OF THE SUTURE BROKE. IT WAS NOTED THAT FOUR SUTURES HAD THE SAME ISSUE. THE SURGICAL TIME WAS EXTENDED. THE USER REPLACED THE DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741320 V-LOC 90 SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN LP LLC NORTH HAVEN VLOCM0134 A3J2064VFY 10884521132276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PLEASE SEE NOTE ON H11.