BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHARPOINT

    MDR report key: 16403981 · Received February 20, 2023

    Report

    Report Number
    3010692967-2023-00007
    Event Type
    Injury
    Date Received
    February 20, 2023
    Date of Event
    January 18, 2023
    Report Date
    February 19, 2023
    Manufacturer
    SURGICAL SPECIALTIES
    Product Code
    GAM
    UDI-DI
    10848782014535
    PMA / PMN Number
    K965162
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED FINISHED GOOD LOT AND RAW MATERIAL COMPONENTS IDENTIFIED NO QUALITY ISSUES DURING THE INCOMING, MANUFACTURING, IN-PROCESS, OR FINAL INSPECTION PROCESSES. NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT. NO SAMPLES OR PHOTOGRAPHS OF THE INCISION/SURGICAL SITE WERE PROVIDED FOR REVIEW OR TESTING. IF STERILE SAMPLES FROM THIS LOT OR PHOTOGRAPHS BECOME AVAILABLE AT A LATER TIME, THE DEVICES AND/OR PHOTOS WILL BE REVIEWED AND/OR TESTED AND THE RESULTS WILL BE INCLUDED IN THE FILE. A REVISED RESPONSE WILL BE SUBMITTED AT THAT TIME. PGA SUTURE MATERIAL CAN CHANGE COLOR, BECOME BRITTLE; BREAK EASILY IF EXPOSED MORE THAN THE RECOMMENDED TIME FOR THIS TYPE OF MATERIAL. SURGICAL SPECIALTIES DOCUMENTS THE EXPOSURE TIME THROUGHOUT THE INSPECTION AND MANUFACTURING PROCESSES TO PREVENT OVER-EXPOSURE PRIOR TO PACKAGING THE DEVICES. THE EXPOSURE TIME FOR THE REPORTED LOT WAS REVIEWED AND MET ALL CURRENT CRITERIA. ADVERSE EVENTS INCLUDING WOUND DEHISCENCE AND REACTIONS ARE COMMON RISKS/COMPLICATIONS OF ANY SURGICAL PROCEDURE. THERE ARE MANY CAUSES THAT CAN RESULT IN THE WOUND OPENING, SUTURES FAILING OR REACTION, INFECTION, ABSCESS/LEAKAGE DURING OR POST-OPERATIVE A PROCEDURE: ¿ THE PATIENT¿S HEALTH STATUS, POOR SKIN QUALITY, THIN SKIN; THE RISK IS HIGHER WITH A PATIENT WITH A WEAK IMMUNE SYSTEM, MALNUTRITION, OR CHRONIC MEDICAL CONDITION. ¿ THE SURGICAL PROCEDURE ¿ THE RISK INCREASES WITH POOR SURGICAL TECHNIQUES SUCH AS IMPROPER SUTURING, OVERTIGHTENED SUTURES OR INAPPROPRIATE TYPE OF SUTURE USED FOR A PARTICULAR PROCEDURE. ¿ OTHER FACTORS - THE RISK IS GREATER WITH SMOKING, OBESITY, PREMATURE POST-SURGERY EXERCISE AND HEAVY LIFTING. THE WARNING SECTION IN THE IFU STATES, ¿THIS AN ABSORBABLE MATERIAL, THE USE OF SUPPLEMENTAL NON ABSORBABLE SUTURES SHOULD BE CONSIDERED BY THE SURGEON IN THE CLOSURE OF SITES WHICH MAY UNDERGO EXPANSION, STRETCHING OR DISTENTION OR WHICH MAY REQUIRE ADDITIONAL SUPPORT¿. THIS IS A SINGLE-USE DEVICE. PGA SUTURES LOSE 25% TENSILE STRENGTH AFTER 2 WEEKS, 50% AFTER 3 WEEKS AND 75 % AFTER 4 WEEKS OF IMPLANTATION AND ARE COMPLETELY ABSORBED IN 60-90 DAYS. RETAINS 50% KNOT TENSILE STRENGTH UP TO 21 DAYS. ABSORPTION TAKES PLACE WITH LOSS OF MASS OF THE SUTURE. THE ¿PRECAUTIONS¿ SECTION IN THE IFU FOR THE DEVICE STATES: ¿CARE SHOULD BE TAKEN TO AVOID DAMAGE WHEN HANDLING. AVOID CRUSHING OR CRIMPING THE SUTURE MATERIAL WITH SURGICAL INSTRUMENTS SUCH AS NEEDLE HOLDERS AND FORCEPS. THE SURGEON SHOULD AVOID UNNECESSARY TENSION, TO REDUCE THE OCCURRENCE OF SURFACE FRAYING AND WEAKENING OF THE STRAND. TO AVOID DAMAGING NEEDLE POINTS AND SWAGE AREAS, GRASP THE NEEDLE IN AN AREA ONE THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE SWAGED END TO THE POINT.¿ WITHOUT RECEIVING STERILE SAMPLES FROM THE REPORTED LOT TO REVIEW/TEST, RECEIVING PHOTOS OF THE SUTURE/INCISION(S) POST-OPERATIVE, OR RECEIVING DETAILED INFORMATION REGARDING THE PRE-OPERATIVE PREPARATION OF THE DEVICE, PROCEDURE(S) PERFORMED, PLACEMENT OF THE SUTURE IN THE TISSUE, PATIENT¿S HEALTH HISTORY, POST-OPERATIVE ACTIVITIES, RECEIVING DETAILS REGARDING NUMBER OF DAYS POST-OPERATIVE THE EVENT OCCURRED, QUALITY OF THE TISSUE WHERE MATERIAL WAS PLACED, EVENTS THAT MAY HAVE OCCURRED THAT ATTRIBUTED TO THE ADVERSE EVENT OR THE SURGEON¿S TECHNIQUE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 0

    SUTURE BROKEN WHEN WOUND WAS HEALING. ON (B)(6), 2023, THE NURSE FOUND THAT THE PATIENT''S WOUND SUTURES WERE BROKEN, RESULTING IN POOR WOUND HEALING, SO SHE EXPLAINED TO THE PATIENT THAT SHE WAS CONSIDERING THE QUALITY OF THE PRODUCT THAT CAUSED THE SUTURES TO BREAK AND REPORTED IT AS AN ADVERSE EVENT. A SMALL AMOUNT OF YEAST GROWTH BACTERIA PRESENT. COMBINED MEDICAL TREATMENT POST-OPERATIVE DUE TO POOR WOUND HEALING OF THE LATERAL INCISION. PATIENT HEALTH IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927319 SHARPOINT T8 2-0 VIO BR PGA 36"/90CM GAM SURGICAL SPECIALTIES G354N AAHZ830 10848782014535

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention