BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFSILK

    MDR report key: 23401583 · Received October 28, 2025

    Report

    Report Number
    9612501-2025-02816
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 8, 2025
    Report Date
    January 2, 2026
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAP
    UDI-DI
    10884521085305
    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 PRODUCTS: GSJ-33-M, GSJ-33-M SOFSILK 3/0 BLKCV-25DT5X45CMX24 (LOT#:D4M1285Y) 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

    H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE VISUAL INSPECTION OF THE OPENED SAMPLES NOTED TWO SUTURES AND FOUR NEEDLES. TWO NEEDLES WERE RECEIVED BROKEN AT THE NEEDLE TIPS. UPON MICROSCOPIC INSPECTION, INSTRUMENT MARKS WERE OBSERVED NEAR THE BREAK SITES. IT WAS REPORTED THAT IT HAD BROKEN TIPS. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THIS ISSUE COULD OCCUR IF THE NEEDLE WAS GRASPED NEAR THE SWAGED END OR THE TIP AND COULD CAUSE BENDS, BREAKS, OR DAMAGE THE CONNECTION BETWEEN THE NEEDLE AND SUTURE. THE EVALUATION DETECTED AN UNREPORTED CONDITION: BENT NEEDLE AND NEEDLE DETACHED. VISUAL EXAMINATION NOTED THAT ONE OF THE BROKEN NEEDLES WAS NOTED TO BE BENT AT 2/3 OF ITS LENGTH FROM THE NEEDLE TIP. ONE SUTURE WAS RECEIVED ATTACHED AND ONE DETACHED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: IN HANDLING THIS OR ANY OTHER SUTURE MATERIAL, CARE SHOULD BE TAKEN TO AVOID DAMAGE FROM HANDLING. AVOID CRUSHING OR CRIMPING DAMAGE DUE TO APPLICATION OF SURGICAL INSTRUMENTS, SUCH AS FORCEPS OR NEEDLE HOLDERS. 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, TWO OF THE FIVE DETACHABLE NEEDLES HAD BROKEN TIPS. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2293052 SOFSILK SUTURE, NONABSORBABLE, SILK GAP DAVIS & GECK CARIBE LTD GSJ-33-M D4M1285Y 10884521085305

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11.