BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK ANTEROMEDIAL FEMORAL AIMER 7.5MM

    MDR report key: 4122550 · Received September 26, 2014

    Report

    Report Number
    1221934-2014-00425
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUALLY THE DEVICE APPEARS IN USED CONDITION. THERE WAS NO EVIDENT DAMAGE AT THE DISTAL END OF THE AIMER EXCEPT FEW NICKS AND MARKS INDICATING THE METAL SHAVINGS DID NOT EMANATE FROM THE FEMORAL AIMER. FURTHERMORE, THE LOT NUMBER PROVIDED IS THE CORRECT LOT NUMBER BUT ONLY THE PART NUMBER WHICH PRECLUDES CONDUCTING A LOT HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. NO FURTHER PATIENT CONSEQUENCES HAVE BEEN REPORTED AND THEREFORE AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. IT WAS REPORTED THAT THE DEVICE IS 3 YEARS OLD AND IS WORN. HOWEVER, DEPUY 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

    THE SALES REP REPORTED THAT DURING AN ACL REPAIR THAT THE CUSTOMER'S ANTEROMEDIAL FEMORAL AIMER 7.5MM CREATED METAL SHAVINGS WHEN THE GUIDE PIN WAS DRILLING INSIDE THE PATIENT'S JOINT SPACE. THE SURGEON REMOVED THE SHAVINGS WITH A GRASPER AND THE SHAVER TO CLEAN OUT THE AREA. NO METAL SHAVING WERE LEFT INSIDE THE PATIENT'S JOINT SPACE. THE SURGEON COMPLETED THE PROCEDURE WITH NO PATIENT CONSEQUENCES. THERE WAS A FIVE MINUTE DELAY IN THE CASE. THE SALES REP COULD NOT PROVIDE A LOT NUMBER BUT REPORTED THAT THE DEVICE IS OVER 3 YEARS OLD AND IS WORN.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT DURING AN ACL REPAIR THAT THE CUSTOMER'S ANTEROMEDIAL FEMORAL AIMER 7.5MM CREATED METAL SHAVINGS WHEN THE GUIDE PIN WAS DRILLING INSIDE THE PATIENT'S JOINT SPACE. THE SURGEON REMOVED THE SHAVINGS WITH A GRASPER AND THE SHAVER TO CLEAN OUT THE AREA. NO METAL SHAVING WERE LEFT INSIDE THE PATIENT'S JOINT SPACE. THE SURGEON COMPLETED THE PROCEDURE WITH NO PATIENT CONSEQUENCES. THERE WAS A FIVE MINUTE DELAY IN THE CASE. THE SALES REP COULD NOT PROVIDE A LOT NUMBER BUT REPORTED THAT THE DEVICE IS OVER 3 YEARS OLD AND IS WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601336 MITEK ANTEROMEDIAL FEMORAL AIMER 7.5MM ARTHROSCOPIC ACL INSTRUMENT LXH DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1