BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMBOTTE OSTEOTOME STR 1/4IN W LGTH 9IN

    MDR report key: 6710326 · Received July 13, 2017

    Report

    Report Number
    1423507-2017-00091
    Event Type
    Malfunction
    Date Received
    July 13, 2017
    Date of Event
    June 21, 2017
    Report Date
    July 13, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    HWM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ON (B)(6) 2017 WRITER SENT THE CUSTOMER AN EMAIL ACKNOWLEDGING RECEIPT OF THE COMPLAINT, PROVIDING THE COMPLAINT TRACKING NUMBER AND REQUESTED FOLLOW UP INFORMATION INCLUDING AS TO IF THERE WAS ANY PATIENT IMPACT RELATED TO THIS EVENT. WRITER PROVIDED CONTACT INFORMATION. DEVICE NOT YET EVALUATED, IF THE DEVICE IS EVALUATED A FOLLOW UP WILL BE SENT.

    Description of Event or Problem · 1

    SALES REP STATED VIA EMAIL: INSTRUMENT BROKE. THE 27JUN2017 ADDITIONAL INFORMATION: WHAT WAS THE PROCEDURE THAT WAS BEING PERFORMED? ELBOW ARTHROSCOPY W/OPEN ULNAR NERVE AND ENDOSCOPIC CARPAL TUNNEL. DID ANY PART THE INSTRUMENT FALL INTO THE PATIENT'S BODY, AND IF SO HOW WAS IT RETRIEVED? TIP BROKE OFF IN ELBOW RETRIEVED WITH GRASPER. WAS THERE A MEDICAL PROCEDURE PERFORMED TO VERIFY IF THE INSTRUMENT WAS IN THE PATIENT'S BODY, SUCH AS AN X-RAY? NO X-RAY OR OTHER PROCEDURE PREFORMED. WHAT WAS THE PATIENT'S OUTCOME? GOOD OUTCOME. WAS THE PROCEDURE COMPLETED AS PLANNED? PROCEDURE WAS COMPLETED AS PLANNED CAN YOU PLEASE SEND ALL PARTS OF THE INSTRUMENT FOR EVALUATION? SENDING IN TO DAY DO YOU HAVE THE LOT#? NO LOT # ITEM # 1060-006. WHAT EXACTLY BROKE? TIP BROKE OFF NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490436 LAMBOTTE OSTEOTOME STR 1/4IN W LGTH 9IN OSTEOTOME HWM CAREFUSION, INC OS1060-006 XRBX06

    Patients

    Seq Age Sex Outcome Treatment
    1