BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LXH

    MDR report key: 5667442 · Received May 19, 2016

    Report

    Report Number
    1220246-2016-00221
    Event Type
    Injury
    Date Received
    May 19, 2016
    Date of Event
    April 25, 2016
    Report Date
    April 25, 2016
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. 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 DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION THEREFORE 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. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. 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. DEVICE DISCARDED BY CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE DRILL FROM THE KIT GOT STUCK IN THE HANDLE AND IT WAS NOT POSSIBLE TO CORRECTLY FINISH THE BONE TUNNEL. SURGEON OPENED A SECOND KIT OF THE SAME LOT AND TRIED TO FINISH THE TUNNEL WITH THE NEW DRILL BUT AGAIN THE DRILL GOT STUCK. A DRILL FROM THE HOSPITAL WAS THEN USED TO CORRECTLY PREPARE A SECOND BONE TUNNEL TO INSERT THE IMPLANT. SURGERY WAS FINISHED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322832 LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ARTHREX, INC. 10026711

    Patients

    Seq Age Sex Outcome Treatment
    1 Other