BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEP DRILL, 2.4MM/3.0MM TISSUETAK/BIO-SUTURETAK

    MDR report key: 2163039 · Received July 15, 2011

    Report

    Report Number
    1220246-2011-00106
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    HTW
    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 CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THE COMPLAINANT'S EVENT IS TYPICALLY CAUSED BY APPLYING LEVERAGE FORCE RESULTING IN IMPROPER ALIGNMENT THAT IS NOT CO-AXIAL WITH THE GUIDE SETUP. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DISPOSITION UNKNOWN.

    Description of Event or Problem · 1

    THE DRILL (AR-1250LT) WAS BROKEN IN OPERATION. THE DRILL TIP WAS IN THE CAVITAS GLENOIDALIS, CAN'T BE TAKEN OUT. THE OPERATION WAS A SHOULDER INSTABILITY REPAIR. THE DRILL WAS USED FOR 4 MONTHS, ABOUT 40 OPERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEP DRILL, 2.4MM/3.0MM TISSUETAK/BIO-SUTURETAK BIT, DRILL HTW ARTHREX, INC. 336153

    Patients

    Seq Age Sex Outcome Treatment
    1 Other