BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BURR, OVAL, CLEARCUT, 8 FLUTE, 5.0MM X 13CM

    MDR report key: 3607767 · Received February 5, 2014

    Report

    Report Number
    1220246-2014-00007
    Event Type
    Injury
    Date Received
    February 5, 2014
    Date of Event
    December 18, 2013
    Report Date
    January 15, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    GFF
    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

    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 REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFORMATION PROVIDED, THIS TYPE OF EVENT IS TYPICALLY CAUSED BY EXCESSIVE BENDING FORCES 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. CUSTOMER WILL NOT RETURN THE DEVICE.

    Additional Manufacturer Narrative · 1

    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. IN THE ORIGINAL SUBMISSION, THE DEVICE WAS NOT RELEASED BY THE FACILITY. THIS FOLLOW-UP SUBMISSION IS TO REPORT ON THE EVALUATION FINDINGS FROM THE RETURNED DEVICE. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THE EVENT. THE COMPLAINT WAS CONFIRMED. THE EVALUATION REVEALED THAT THE CLEAR HOOD DETACHED FROM THE DEVICE. FURTHER EVALUATION ALSO REVEALED A BENT OUTER SHAFT. THIS TYPE OF EVENT IS TYPICALLY CAUSED BY EXCESSIVE LEVERAGING/BENDING FORCES APPLIED TO THE DEVICE DURING USE. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, ANOTHER FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLEARCUT SHIELD DETACHED FROM THE BURR WHEN IT WAS INSERTED INTO PATIENT´S HIP. AN ELONGATED EXTRA INCISION WAS NEEDED TO REMOVE THE SHIELD FROM PATIENT, BUT IT WAS NOT POSSIBLE TO GET IT. THE SHIELD IS STILL IN SITU. THE PATIENT WAS INFORMED. IT WILL TAKE UP TO 3 MONTHS UNTIL IT BECOMES CLEAR IF A REVISION WILL BE DONE. IF THE PATIENT DOES NOT HAVE ANY PAIN/ DISCOMFORT THERE WON´T BE A REVISION. THE PART WILL NOT BE RELEASED BY THE FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLEARCUT SHIELD DETACHED FROM THE BURR WHEN IT WAS INSERTED INTO PATIENT'S HIP. AN ELONGATED EXTRA INCISION WAS NEEDED TO REMOVE THE SHIELD FROM PATIENT. NO DEVICE FRAGMENTS WERE LEFT. THE PATIENT WAS INFORMED ABOUT THIS CASE. IT WILL TAKE UP TO 3 MONTHS UNTIL IT BECOMES CLEAR IF A REVISION WILL BE DONE. IF THE PATIENT DOES NOT HAVE ANY PAIN/ DISCOMFORT THERE WON'T BE A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74165 BURR, OVAL, CLEARCUT, 8 FLUTE, 5.0MM X 13CM BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF ARTHREX, INC. 967248

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other