BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK DRILL PIN WITH EYELET .094X14

    MDR report key: 3935625 · Received July 15, 2014

    Report

    Report Number
    1221934-2014-00301
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 17, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL INSPECTION CONFIRMS THE DRILL BIT IS BROKEN AT THE PROXIMAL END OF THE DRILL'S FLUTES. THE SHANK PART OF THE DRILL HAS MULTIPLE SLIP MARKS AND SCRATCHES, INDICATING THAT THE DRILL BIT WAS IN CONTACT WITH ANOTHER SURFACE DURING THE DRILLING ACTION. MOREOVER, THE SHAFT IS SLIGHTLY BENT AND TWISTED AT TWO SPOTS. THE EYELET PIECE IS BENT, WHICH MIGHT HAVE CONTRIBUTED IN THE INCORRECT DRILL ALIGNMENT. THE BROKEN DISTAL END OF THE DRILL BIT WAS EXAMINED UNDER MAGNIFICATION AND THERE IS AN INDICATION THAT THE FAILURE WAS CAUSED BY TWISTING ACTION DURING DRILLING. THERE IS A METAL BURR AT ONE SIDE ONLY AT THE BREAKAGE LOCATION. NO FURTHER INFORMATION WAS PROVIDED WITH THE REPORTED COMPLAINT. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. ALTHOUGH, A BATCH NUMBER WAS NOT PROVIDED, A SEARCH BY THE PRODUCT NUMBER WAS DONE FROM 2012-2014 AND NO OTHER COMPLAINTS FROM ANY LOT WERE FOUND. WITHOUT ANY INFORMATION REGARDING THE BONE QUALITY OR HOW THE REPORTED INCIDENT TOOK PLACE, WE CANNOT DISCERN A ROOT CAUSE FOR THIS FAILURE AT THIS TIME; OTHER THAN THE POSSIBILITIES MENTIONED ABOVE. AT THIS POINT, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. 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. IN TRANSIT.

    Description of Event or Problem · 1

    DAMAGED DEVICE. IN A CRUCIATE LIGAMENT SURGERY, WHEN PLACING THE TIP CHAST, THIS ONE BROKE IN INTRA-ARTICULAR IN THE KNEE. PIECE OF TIP LEFT IN PLACE.

    Description of Event or Problem · 1

    DAMAGED DEVICE. IN A CRUCIATE LIGAMENT SURGERY, WHEN PLACING THE TIP CHAST, THIS ONE BROKE IN INTRA-ARTICULAR IN THE KNEE. PIECE OF TIP LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411800 MITEK DRILL PIN WITH EYELET .094X14 ACL DRILL BIT NBH DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1