BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSYN

    MDR report key: 21599294 · Received March 13, 2025

    Report

    Report Number
    9612501-2025-00755
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 21, 2025
    Report Date
    May 16, 2025
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAM
    UDI-DI
    10884521033269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, 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 NEEDLE WAS RETURNED DISENGAGED FROM THE SUTURE. THE SUTURE WAS RETURNED WOUND WITHIN THE RETAINER. UPON MICROSCOPIC INSPECTION OF THE NEEDLE, NORMAL CRIMP AND SWAGE MARKS WERE NOTED. SUTURE MATERIAL WAS OBSERVED TO BE PRESENT IN THE SWAGE, INDICATING THE SUTURE BROKE OFF AT THE SWAGE. FUNCTIONAL TESTING FOUND THAT THE OPENED COMPLAINT DEVICE WAS PRECLUDED AS THE NEEDLE WAS RETURNED ALREADY DETACHED. 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. 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 PRODUCTS: SM822 SM-822 BIOSYN 3-0 UND 75CM C13 X36 - (LOT#D2J1841FY); SM822 SM-822 BIOSYN 3-0 UND 75CM C13 X36 - (LOT#D2J1841FY); SM822 SM-822 BIOSYN 3-0 UND 75CM C13 X36 - (LOT#D2J1841FY); SM822 SM-822 BIOSYN 3-0 UND 75CM C13 X36 - (LOT#D2J1841FY) 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

    IT WAS REPORTED THAT AT THE TIME OF SUTURING ON A PLASTIC SURGERY, SEVERAL THREADS OF BIOSYN 3/0 SM-822 WERE USED AND SUDDENLY CAME LOOSE DURING THE SUTURE LEAVING THE NEEDLE IN THE SKIN. FOUR OTHER THREADS USED WITH THE NEEDLE REMAINED STUCK IN THE PATIENT'S SKIN. WHEN THE THREADS CAME LOOSE DURING SUTURING, THE DOCTOR HAD TO REMOVE THE NEEDLES FROM THE SKIN USING THE INSTRUMENTS USED DURING SUTURING, THE NEEDLE HOLDER AND CLAW FORCEPS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AT THE TIME OF SUTURING ON A PLASTIC SURGERY , SEVERAL THREADS OF BIOSYN 3/0 SM-822 WERE USED AND SUDDENLY CAME LOOSE DURING THE SUTURE LEAVING THE NEEDLE IN THE SKIN. FOUR OTHER THREADS USED WITH THE NEEDLE REMAINED STUCK IN THE PATIENT'S SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495531 BIOSYN SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM DAVIS & GECK CARIBE LTD SM822 D2J1841FY 10884521033269

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11