BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEP DRILL, FOR 3.0MM KNOTLESS SUTURE TAK

    MDR report key: 6338826 · Received February 17, 2017

    Report

    Report Number
    1220246-2017-00024
    Event Type
    Injury
    Date Received
    February 17, 2017
    Date of Event
    January 25, 2017
    Report Date
    February 17, 2017
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    UDI-DI
    00888867024212
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. THIS IS ONE OF TWO SUBMISSIONS FROM THE SAME PATIENT EVENT. THE OTHER IS 1220246-2017-00023 (CC104986 LINE 181872). NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE EVALUATION OF THE RETURNED DEVICES REVEALED METAL GOUGES. FURTHER EVALUATION REVEALED THAT THE TWO RETURNED DRILL'S ARE BENT. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT INCLUDE EXCESSIVE BENDING FORCE APPLIED TO THE DEVICE DURING USE. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO 2.6MM DRILLS FOR 3MM SUTURETAK (AR-1938D) ALONG WITH ONE 3MM SUTURETAK PERCUTANEOUS INSERTION KIT (CC104986 LINE181875 AR-1934PI-30) AND ONE TROCAR TIP OBTURATOR FOR 3MM SUTURETAK DISPOSABLE SPEAR (CC104986 LINE 181877 AR-1949S) WERE BEING USED IN A SHOULDER LABRAL REPAIR PROCEDURE. WHILE USING THE FIRST DRILL (CC104986 LINE 181872) WITH A COMPETITORS DEVICE SET AT FULL SPEED ALONG WITH THE DRILL GUIDE FROM AR-1934PI-30 (CC104986 LINE 181875), IT WAS NOTICED THAT THERE WERE METAL SHAVINGS BEING PRODUCED INSIDE THE PATIENT. AN ATTEMPT WAS MADE TO REMOVE THE METAL SHAVINGS FROM THE PATIENT BY USING A FRAZIER TIP SUCTION DEVICE AND HIGH FLOW SHAVER. THE SURGEON WAS UNABLE TO RETRIEVE ALL SHAVINGS. THE SECOND DRILL (CC104986 LINE181874) WAS USED WITH A COMPETITORS DEVICE, ALONG WITH THE DISPOSABLE SPEAR (CC104986 LINE 181877) AND ALSO PRODUCED METAL SHAVINGS. THE SAME TECHNIQUE WAS USED AGAIN TO TRY AND REMOVE THE METAL SHAVINGS, AND AGAIN ALL OF THE SHAVINGS WERE UNABLE TO BE RETRIEVED FROM THE PATIENT. SALES REP STATED THE SURGEON MENTIONED THAT SHE BELIEVES THE METAL SHAVINGS WERE CREATED BY THE DRILL AND DRILL GUIDE COMING IN CONTACT WITH EACH OTHER. A REUSABLE DRILL GUIDE AND A NEW DRILL BIT WITH A COMPETITORS DEVICE WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122588 STEP DRILL, FOR 3.0MM KNOTLESS SUTURE TAK BIT, DRILL HTW ARTHREX, INC. 10049558 00888867024212

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AR-1934PL-30 LOT 10021315 PERC INSERT KIT| AR-1949S LOT 432576 FASTAK II SPEAR W/TROCAR