BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDEWIRE 1.1MM X 15?

    MDR report key: 4222327 · Received November 4, 2014

    Report

    Report Number
    1221934-2014-00478
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE, UNAVAILABLE FOR A PHYSICAL EVALUATION. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. BASED ON THE OVERALL COMPLAINT RATE FOR THIS FAILURE, AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY MITEK, HOWEVER, IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE, DEPUY MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    WHEN DRILLING THE FEMORAL DRILL CHANNEL IT WAS USING THE AT TARGET DEVICE 7.5MM (254687) AND THE GUIDE OR DRILL WIRE (254514) TO METAL DEBRIS IN THE JOINT OF THE PATIENT. (B)(4) TRANSLATER WAS USED FOR THE DESCRIPTION OF THIS COMPLAINT. TRANSLATION FROM AFFILIATE PROCEDURE: REPAIR OF ANTERIOR CRUCIAL LIGAMENT EVENT: WHEN PUSHING THE NITINOL GUIDE WIRE (254514) THROUGH THE METAL TROCAR OF 254687, SURGEON NOTICED METAL SHAVINGS. HE RINSED THOROUGHLY AND COULD REMOVE ALL SHAVINGS. DELAY OF PROCEDURE APPROX. 10 MINUTES. NO FURTHER HARM TO THE PATIENT. GUIDE WIRE HAS BEEN DISCARDED. SURGEON RESTERILIZES GUIDE WIRES SOMETIMES, BUT THIS ONE WAS NEW.

    Description of Event or Problem · 1

    WHEN DRILLING THE FEMORAL DRILL CHANNEL IT WAS USING THE AT TARGET DEVICE 7.5MM (254687) AND THE GUIDE OR DRILL WIRE (254514) TO METAL DEBRIS IN THE JOINT OF THE PATIENT. (B)(4) TRANSLATER WAS USED FOR THE DESCRIPTION OF THIS COMPLAINT. TRANSLATION FROM AFFILIATE PROCEDURE: REPAIR OF ANTERIOR CRUCIAL LIGAMENT EVENT: WHEN PUSHING THE NITINOL GUIDE WIRE (254514) THROUGH THE METAL TROCAR OF 254687, SURGEON NOTICED METAL SHAVINGS. HE RINSED THOROUGHLY AND COULD REMOVE ALL SHAVINGS. DELAY OF PROCEDURE APPROX. 10 MINUTES. NO FURTHER HARM TO THE PATIENT. GUIDE WIRE HAS BEEN DISCARDED. SURGEON RESTERILIZES GUIDE WIRES SOMETIMES, BUT THIS ONE WAS NEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707666 GUIDEWIRE 1.1MM X 15? ACL ACCESSORIES FZX DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1