BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIO-PUSHLOCK 4.5MM X 18.5MM

    MDR report key: 1102167 · Received August 7, 2008

    Report

    Report Number
    1220246-2008-00153
    Event Type
    Other
    Date Received
    August 7, 2008
    Date of Event
    July 16, 2006
    Report Date
    July 17, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K061863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES IN QUESTION WERE NOT RETURNED AND THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED BECAUSE THE PIECES WERE EITHER RETAINED SECURELY IN THE PATIENT OR DISCARDED. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THIS EVENT IS STILL BEING INVESTIGATED AND IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DELAY IN SURGERY OF APPROXIMATELY 90 MINUTES OCCURRED DURING A ROTATOR CUFF REPAIR SURGERY BECAUSE THE EYELET ON THE DEVICE KEPT BREAKING UPON INSERTION. TWO EYELETS WERE RETRIEVED AND TWO WERE TOO DEEP TO REMOVE. THE IMPLANTS WERE PLACED OVER THE UNRETRIEVED EYELETS AND WERE SECURE. THE SURGEON USED A 3.5MM BIO-PUSHLOCK TO COMPLETE THE CASE. PER THE REPORTER, THERE WERE NO FURTHER CONCERNS WITH THE OUTCOME OF THE SURGERY. NO FURTHER PATIENT INFORMATION WAS PROVIDED AND NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THE DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-PUSHLOCK 4.5MM X 18.5MM HWC ARTHREX, INC. NA 164318

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other