BEUDAMED
    FDA Adverse Event Other Summary report: N

    PEEK CORKSCREW FT W/ NEEDLES, 4.5MM

    MDR report key: 1233444 · Received November 11, 2008

    Report

    Report Number
    1220246-2008-00222
    Event Type
    Other
    Date Received
    November 11, 2008
    Date of Event
    January 13, 2008
    Report Date
    October 14, 2008
    Manufacturer
    ARTHREX INC.
    Product Code
    HWC
    PMA / PMN Number
    K061863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR EVAL BUT NOT RETURNED, THEREFORE THE EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND WITHOUT DEVICE EVAL. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS (INSERTER BREAKING) IS THE APPLICATION OF LEVERAGING FORCE DURING INSERTION OF THE ANCHOR. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE MAUDE DATABASE THAT THE DEVICE WAS INSERTED INTO THE LEFT ROTATOR CUFF. THE SMALL TIP OF THE INSERTER (DRIVER) BROKE OFF WHILE ANCHOR WAS BEING PLACED. THE SURGEON WAS UNABLE TO RETRIEVE THE FRAGMENT; THE TIP OF THE INSERTER WAS RETAINED IN THE ANCHOR. FOLLOW-UP WITH THE REPORTER PROVIDED INFO THAT THE CASE WAS COMPLETED BY INSERTING ANOTHER ANCHOR NEXT TO THE BROKEN ONE. THERE WAS A DELAY OF MORE THAN 30 MINUTES IN THE CASE. NO FURTHER PT INFO WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO MULTIPLE FOLLOW-UP COMMUNICATIONS WITH THE INITIAL REPORTER. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEEK CORKSCREW FT W/ NEEDLES, 4.5MM HWC HWC ARTHREX INC. NA 132440

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other