BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFSILK

    MDR report key: 14104119 · Received April 13, 2022

    Report

    Report Number
    9612501-2022-00555
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    March 4, 2022
    Report Date
    April 26, 2022
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAP
    UDI-DI
    10884521085220
    PMA / PMN Number
    K981128
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, G3 MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING A SURGERY, WHEN THE SURGEON PUT NEEDLE ON NEEDLE HOLDER, THE SUTURE BROKE. A PIECE FELL ON THE FLOOR THAT CHARGE NURSE INFORMED THE STAFF AND MAGNET SWEEPER WAS BROUGHT TO ROOM. REMAINING PIECE OF SUTURE WAS FOUND. BOTH PIECES OF NEEDLE WERE PLACED IN SPECIMEN CUP WITH SUTURE LABEL. THE SURGEON COMPARED BOTH BROKEN PIECES TO A SUTURE OF SAME SIZE AND DIAMETER AND DETERMINED THAT THEY MATCHED. ALL OPERATING AND ANESTHESIA STAFF AGREED THAT ALL PIECES OF SUTURE NEEDLE WERE OBTAINED. PATIENT WAS NOT AFFECTED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING THYROID LOBECTOMY, WHEN THE SURGEON PUT NEEDLE ON NEEDLE HOLDER, THE SUTURE BROKE. A PIECE FELL ON FLOOR, THAT CHARGE NURSE INFORMED STAFF AND MAGNET SWEEPER WAS BROUGHT TO ROOM. REMAINING PIECE OF SUTURE WAS FOUND. BOTH PIECES OF NEEDLE WERE PLACED IN SPECIMEN CUP WITH SUTURE LABEL. THE SURGEON COMPARED BOTH BROKEN PIECES TO A SUTURE OF SAME SIZE AND DIAMETER AND DETERMINED THAT THEY MATCHED. ALL OPERATING AND ANESTHESIA STAFF AGREE THAT ALL PIECES OF SUTURE NEEDLE WERE OBTAINED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709787 SOFSILK SUTURE, NONABSORBABLE, SILK GAP DAVIS & GECK CARIBE LTD GS-832 D1K1768Y 10884521085220

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown