BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYROMITE 2.0 PK W/1 2-0 ULTRABRAID WH

    MDR report key: 9580700 · Received January 13, 2020

    Report

    Report Number
    1219602-2020-00076
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Date of Event
    December 17, 2019
    Report Date
    February 29, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    UDI-DI
    03596010619075
    PMA / PMN Number
    K081511
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3,H6: THE REPORTED SPYROMITE 2.0 PK W/1 2-0 ULTRABRAID, USED IN TREATMENT, HAS BEEN RETURNED FOR EVALUATION. VISUAL ASSESSMENT OF THE DEVICE COULD NOT CONFIRM THE REPORTED BREAKAGE. THE ANCHOR IS BENT AT ITS DISTAL END. THE CONDITION OF THE ANCHOR SUGGESTS THE ANCHOR WAS SUBJECTED TO EXCESSIVE FORCE DURING INSERTION CAUSING THE REPORTED DAMAGE. PER THE DEVICE INSTRUCTIONS FOR USE ¿USE OF EXCESSIVE FORCE DURING INSERTION CAN CAUSE FAILURE OF THE SUTURE ANCHOR OR INSERTION DEVICE¿. A REVIEW OF THE MANUFACTURING AND COMPLAINT RECORDS WAS PERFORMED FOR THE REPORTED LOT, THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE BROKE WHEN TURNING IT AFTER IT WAS INSERTED. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45223 SPYROMITE 2.0 PK W/1 2-0 ULTRABRAID WH FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. 72201882 50775489 03596010619075

    Patients

    Seq Age Sex Outcome Treatment
    1