BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENODESIS SCREW, PEEK

    MDR report key: 3142316 · Received June 3, 2013

    Report

    Report Number
    1220246-2013-00088
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K051726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    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 PART REMAINS IN THE PATIENT AND CANNOT BE RETURNED AND THE REMAINING PART WAS DISCARDED BY THE FACILITY, 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. THE MOST LIKELY CAUSE MAY BE AS DESCRIBED IN THE EVENT DESCRIPTION THAT THE SURGEON WAS TRYING TO REMOVE THE INSERTERS, MOVING IT FROM SIDE TO SIDE WHEN THE TIPS BROKE OFF. OTHER MOST LIKELY CAUSE(S) INCLUDE CONTINUALLY APPLYING TORQUE AFTER THE SCREW IS FULLY SEATED, TORQUING WHEN THE IMPLANT IS NOT PROPERLY ALIGNED, LEVERAGING AND TORQUING WHILE LEVERAGING THE DEVICE. 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 INSERTERS BROKE ON REMOVAL. THE INSERTER TIP BROKE ON INSERTION, FLUSH WITH THE SCREW. AN ATTEMPT WAS MADE TO RETRIEVE THE BROKEN TIP, BUT IT WAS PUSHED DOWN FURTHER INTO THE SCREW AND COULD NOT BE REMOVED WITHOUT DAMAGING THE SCREW. ANOTHER ONE WAS INSERTED WITH THE SAME OUTCOME BROKEN FLUSH WITH SCREW HEAD. THE SURGEON WAS TRYING TO REMOVE THE INSERTERS AND MOVING IT FROM SIDE TO SIDE WHEN THE TIPS BROKE OFF. HAND PROCEDURE CMC ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243245 TENODESIS SCREW, PEEK SCREW, FIXATION, BONE HWC ARTHREX, INC. 573854

    Patients

    Seq Age Sex Outcome Treatment
    1 Other