BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIO-PUSHLOCK 3.5MM X 14MM

    MDR report key: 1200208 · Received October 6, 2008

    Report

    Report Number
    1220246-2008-00203
    Event Type
    Other
    Date Received
    October 6, 2008
    Date of Event
    August 7, 2008
    Report Date
    September 11, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K03816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETAINED IN THE PATIENT AND WAS NOT ABLE TO BE RETURNED FOR EVALUATION. THE LOT NUMBER WAS REQUESTED BUT NOT PROVIDED, THEREFORE, THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY OF THE DEVICE COULD NOT BE REVIEWED. THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS DRILLING THE HOLE IN THE GLENOID AT SUCH AN ANGLE THAT IT IS DRILLED ALL THE WAY THROUGH THE GLENOID INSTEAD OF INTO THE GLENOID NECK; A HOLE CREATED AT THIS ANGLE WILL HAVE NO "BOTTOM'. IF THIS OCCURS, THE HOLE MAY ALLOW THE SURGEON TO INSERT THE ANCHOR ALL THE WAY THROUGH THE GLENOID AND "LOOSE" IT. IF THE ANCHOR IS LOST BEYOND THE GLENOID, IT WOULD BE RETAINED EXTRACAPSULAR. IN THIS REPORTED EVENT, IT WAS ALSO NOTED THAT THE SURGEON USED A COMPETITOR'S DRILL TO CREATE THE PILOT HOLE; INCONSISTENCIES IN SIZING MAY HAVE OCCURRED WHICH CREATED A HOLE THAT WAS WAY TOO LARGE FOR THE IMPLANT. ANTHREX DOES NOT MANUFACTURE ANY INSTRUMENTATION (DRILLS OR DRILL GUIDES) TO INSERT 4.5MM SIZED PUSHLOCKS INTO THE GLENOID. SINCE ARTHREX DOES NOT PROVIDE ANY ACCESSORIES TO FACILITATE THE USE OF 4.5MM PUSHLOCKS IN GLENOID REPAIRS, IT IS THE SURGEON'S RESPONSIBILITY TO SELECT APPROPRIATE ACCESSORIES TO ALLOW FOR THE SAFE USE OF THE DEVICE. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGEON WAS PERFORMING A LABRAL REPAIR. HE INSERTED TWO SMITH & NEPHEW IMPLANTS, BROKE THEM, THEN REMOVED THEM. HE THEN DRILLED THROUGH THE GLENOID AND PUSHED THE ARTHREX PUSHLOCK RIGHT THROUGH THE GLENOID AND IT DISAPPEARED INTO THE JOINT SPACE. DESPITE EXTENSIVE SEARCH, HE WAS UNABLE TO LOCATE THE IMPLANT. FOLLOW-UP WITH THE REPORTER PROVIDED INFORMATION THAT A HOLE WAS DRILLED FOR A 2.9 ANCHOR, KINSA. THE PATIENT BONE WAS GOOD QUALITY. THE HOLE, WHICH WAS AT THE SEVEN O'CLOCK POSITION ANCHOR LOWEST ON THE GLENOID FACE, WAS TOO LARGE FOR THE ANCHOR. A 4.5 PUSHLOCK WAS PLACED IN THE HOLE; IT PUSHED ALL THE WAY THROUGH AND WAS NOT ABLE TO BE LOCATED OR RETRIEVED. THE SURGEON DID NOT THINK IT WAS RETAINED IN THE BONE. THE NEXT TWO HOLES DRILLED WITH THE SAME DRILL WERE MUCH TIGHTER AND THE KINSAS SEATED WELL. THE CASE WAS COMPLETED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR IN RESPONSE TO FOLLOW-UP COMMUNICATION. 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 BIO-PUSHLOCK 3.5MM X 14MM HWC ARTHREX, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YEAR Other INFORMATION REQUESTED BUT NOT PROVIDED.