BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    MDR report key: 4834198 · Received June 8, 2015

    Report

    Report Number
    3008845715-2015-00052
    Event Type
    Other
    Date Received
    June 8, 2015
    Report Date
    June 4, 2015
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC.
    Product Code
    NEW
    PMA / PMN Number
    K113744
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED WILL NOT BE RETURNED. RESULTS/ CONCLUSIONS: THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED WILL NOT BE RETURNED. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED. FINISHED GOOD PRODUCT AS WELL AS THE SUTURE COMPONENT WERE RECEIVED INTO INVENTORY WITHOUT QUALITY ISSUES. THE PRODUCT FROM THIS FINISHED GOOD LOT AND ALL OF THE COMPONENTS MET SURGICAL SPECIALITIES PUERTO RICO INC. REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING AND THE FINAL INSPECTION PROCESSES. NO INVENTORY AVAILABLE FOR THE FINISHED GOOD LOT REPORTED. DEHISCENCE, IS A KNOWN RISK WITH ANY SUTURE MATERIAL. THE MOST PROBABLY ROOT CAUSE FOR POST OPERATIVE DEHISCENCE CAN NOT BE DETERMINED WITH CERTAINTY BASED ON THE INFORMATION PROVIDED, WITHOUT REVIEWING THE ACTUAL DEVICE INVOLVED OR REVIEWING OR TESTING, STERILE SAMPLES FROM THE SAME FINISHED GOODS LOT. (B)(4) -ITEM #SXPD1B100 STRATAFIX SPIRAL PDO KNOTLESS TISSUE CONTROL DEVICE -PS-2 #2-0 PDO 45CM, LOT MCJH230.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP, THAT IN 8 DIFFERENT CASES OF WOUND DEHISCENCE WERE EXPERIENCED 2-3 WEEKS POST-OP WHERE STRATAFIX DEVICES WERE USED TO CLOSE SUBCUTANEOUS TISSUE LAYER. SURGEON CLOSED THE INCISION WITH STANDARD SUTURE. ADDITIONAL INFORMATION FROM ATTACHED SYNERGY FORM: WOUND DEHISCENCE 2-3 WEEKS POST-OP. 3-4 CM LONG INCISION. DATES OF EVENTS NOT REPORTED. DR. LEBLANC DID NOT HAVE ANY SIMILAR ISSUES USING SAME DEVICE ON LONGER INCISION. REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE. HAD TO CLOSE INCISION WITH STANDARD SUTURE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367658 STRATAFIX KNOTLESS TISSUE CONTROL DEVICE BARBED MATERIAL/NEEDLES NEW SURGICAL SPECIALTIES PUERTO RICO INC. SXPD1B100 MCJH230

    Patients

    Seq Age Sex Outcome Treatment
    1 NA NONE MADE AVAILABLE.