BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIPRO II

    MDR report key: 18530947 · Received January 17, 2024

    Report

    Report Number
    9612501-2024-00172
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    December 27, 2023
    Report Date
    March 16, 2024
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAW
    UDI-DI
    10884521038974
    PMA / PMN Number
    K050947
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: VP-74-X, VP-74-X SURGIPRO II 6-0 BLU 60CM CVDA OP, (LOT#: D2L2415Y) VP-74-X, VP-74-X SURGIPRO II 6-0 BLU 60CM CVDA OP, (LOT#: D2L2415Y) VP-74-X, VP-74-X SURGIPRO II 6-0 BLU 60CM CVDA OP, (LOT#: D2L2415Y) VP-74-X, VP-74-X SURGIPRO II 6-0 BLU 60CM CVDA OP, (LOT#: D2L2415Y) VP-74-X, VP-74-X SURGIPRO II 6-0 BLU 60CM CVDA OP, (LOT#: D2L2415Y). 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.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED, BUT A PHOTO WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED ONE SEALED SAMPLE WITH TWO NEEDLES NOTED TO BE PARKED IN THE RETAINER FOAM. THREE PARTIAL SUTURES AND FOUR PARTIAL NEEDLES. THREE OF THE BROKEN PARTIAL NEEDLES WERE ATTACHED TO A PARTIAL SUTURE AND ONE PARTIAL NEEDLE WAS MISSING THE SWAGED SECTION. IT WAS REPORTED THAT A TOTAL OF SIX NEEDLES WERE BROKEN. 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 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 AN OPEN BREAST REDUCTION SURGERY, WHILE SUTURING THE SKIN, A TOTAL OF SIX NEEDLES WERE BROKEN. AN X-RAY WAS PERFORMED AND THE SURGICAL EXTENSION TOOK TWO HOURS TO FIND THE NEEDLE. A NEW NEEDLE FROM ANOTHER MANUFACTURER WAS USED FOR SUTURING AND COMPLETE THE CASE.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING AN OPEN BREAST REDUCTION SURGERY, WHILE SUTURING THE SKIN, A TOTAL OF SIX NEEDLES WERE BROKEN. AN X-RAY WAS PERFORMED AND THE SURGICAL EXTENSION TOOK TWO HOURS TO FIND THE NEEDLE. IT WAS NOTED THAT THE NEEDLES DID NOT FALL INTO THE PATIENT'S CAVITY. A NEW NEEDLE FROM ANOTHER MANUFACTURER WAS USED FOR SUTURING AND COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817622 SURGIPRO II SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLEN GAW DAVIS & GECK CARIBE LTD VP-74-X D2L2415Y 10884521038974

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other