BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFSILK

    MDR report key: 21054782 · Received January 2, 2025

    Report

    Report Number
    9612501-2025-00005
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    November 29, 2024
    Report Date
    March 7, 2025
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAP
    UDI-DI
    20884521085302
    PMA / PMN Number
    K981128
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: GSJ-33-M, GSJ-33-M SOFSILK 3/0 BLKCV-25DT5X45CMX24 (LOT#D4F2770Y); GSJ-33-M, GSJ-33-M SOFSILK 3/0 BLKCV-25DT5X45CMX24 (LOT#D4F2770Y); GSJ-33-M, GSJ-33-M SOFSILK 3/0 BLKCV-25DT5X45CMX24 (LOT#D4F2770Y). 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

    ADDITIONAL INFORMATION: G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED FIVE SUTURES AND FIVE NEEDLES. ONE NEEDLE WERE RETURNED DISENGAGED FROM ANY SUTURE. FOUR NEEDLES HAD SUTURES ATTACHED AND PROPERLY PARKED WITHIN THE RETAINER. ONE SUTURES WERE DISENGAGED FROM ANY NEEDLE. UPON MICROSCOPIC INSPECTION OF THE NEEDLES, NORMAL CRIMP AND SWAGE MARKS WERE NOTED. FUNCTIONAL TESTING FOUND THAT A NEEDLE ATTACHMENT TEST WAS PERFORMED WITH THE PROPERLY WOUND SUTURES FROM PLIS 10 THROUGH 40. UNFORTUNATELY, A NEEDLE ATTACHMENT TEST COULD NOT BE TESTED ON THE ALREADY DETACHED NEEDLES AND EXPOSED SUTURES. THE TENSILE STRENGTH OF NONABSORBABLE SUTURES MAY BE AFFECTED BY DAMAGE DURING USE AFTER THE PRODUCT HAS BEEN OPENED AND MAY IMPACT THE VALIDITY OF ANY TEST RESULTS. DAMAGE DURING USE MAY RESULT IN INADEQUATE SAMPLE LENGTH TO PERFORM TESTING AND/OR DEFORMATION OF THE SUTURE CONTRIBUTING TO A LOSS IN TENSILE STRENGTH. THE SUTURES WERE REMOVED FROM THE RETAINERS WITHOUT ANY DIFFICULTY. THE SUTURES WERE LOADED ONTO AN INSTRON MACHINE BY CLAMPING THE NEEDLE WITH A PNEUMATIC GRIP WITH A SERRATED FACE AND THE SUTURE END WITH A PNEUMATIC YARN GRIP. NO SUTURE BREAKING OR FRAYING WAS NOTED WHILE HANDLING/LOADING THE SUTURE INTO THE INSTRON MACHINE. THE INSTRON THEN PULLED THE SUTURE AT A RATE OF 300 MM/MIN UNTIL THE NEEDLE DISENGAGED FROM THE SUTURE. THE LOAD FORCE AT THE POINT OF DETACHMENT WAS MEASURED AND WERE FOUND TO MEET USP SPECIFICATIONS. IT WAS REPORTED THAT THE NEEDLE WAS DETACHED. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. 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 PROCEDURE, THE FOUR NEEDLES DETACHED FROM THE THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911145 SOFSILK SUTURE, NONABSORBABLE, SILK GAP DAVIS & GECK CARIBE LTD GSJ-33-M D4F2770Y 20884521085302

    Patients

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