BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSTITCH PP CONNECTOR

    MDR report key: 7249674 · Received February 7, 2018

    Report

    Report Number
    3006524618-2018-00067
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    January 18, 2018
    Report Date
    March 6, 2018
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    NBH
    PMA / PMN Number
    K123268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PERFECTPASSER CONNECTOR, INTENDED FOR USE IN TREATMENT, WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE DEVICE AND REPORTED INCIDENT WAS ESTABLISHED. FROM THE INFORMATION PROVIDED, THE DEVICE FAILED AND DISLODGED FROM THE TIP. VISUAL INSPECTION SHOWS THE CONNECTOR WAS RECEIVED WITH THE S-CLAMP UNHOOKED FROM THE S-HOOK AND THE S-CLAMP WAS NOT RETURNED. ALSO A SUTURE CARTRIDGE IS ATTACHED INTO THE DEVICE. INTERNAL INVESTIGATION INDICATES THE FAILURE CAUSE FOR UPPER S-CLAMP COMING LOOSE IS DUE TO A DIMENSIONAL DISCREPANCY ON THE S-HOOK COMPONENT. CHANGES TO THE COMPONENT HAVE BEEN IMPLEMENTED TO PREVENT THIS FAILURE. 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 THE SELF CAPTURE DEVICE FAILED AND DISLODGED FROM THE TIP OF TWO DEVICES FROM THE LOT 2005153 AND DEVICE FROM LOT 1192014. THE BROKEN PIECES WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. COMPLAINT 1 OF 3. SEE (B)(4) FOR RELATED COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90878 SMARTSTITCH PP CONNECTOR ACCESSORIES,ARTHROSCOPIC NBH ARTHROCARE CORP. 2005153

    Patients

    Seq Age Sex Outcome Treatment
    1