BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8MM X 30MM BIOCRYL RAPIDE INTERFERENCE SCREW

    MDR report key: 4222328 · Received November 4, 2014

    Report

    Report Number
    1221934-2014-00479
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    PMA / PMN Number
    K060830
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS NOT BEEN RETURNED, THEREFORE IS UNAVAILABLE FOR A PHYSICAL EVALUATION. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS OF ANY KIND FOR THIS LOT OF 800 DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE, ALTHOUGH A POSSIBLE ROOT CAUSE WOULD BE THE PATIENT HAVING AN ALLERGIC REACTION TO THE PRODUCT. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND 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. SHOULD THE COMPLAINT DEVICE EVER BE RETURNED AT SOME POINT IN TIME IN THE FUTURE, THIS COMPLAINT FILE WILL BE REOPENED AT THAT TIME, AND AN EVALUATION WILL BE PERFORMED AND DOCUMENTED.

    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 PATIENT HAD AN ALLERGIC REACTION DUE TO THE SCREW. IT HAS BEEN NECESSARY A REINTERVENTION: DURING THE REINTERVENTION THE SCREW WAS FOUND FULLY CRUMBLED.

    Description of Event or Problem · 1

    THE PATIENT HAD AN ALLERGIC REACTION DUE TO THE SCREW. IT HAS BEEN NECESSARY A REINTERVENTION: DURING THE REINTERVENTION THE SCREW WAS FOUND FULLY CRUMBLED. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM OUR AFFILIATE AND SUMMARIZED BY A MITEK COMPLAINT ANALYST; AN ALLERGIC REACTION WAS NOTICED SOMEWHERE BETWEEN 2 WEEKS AND SEVERAL WEEKS AFTER AN INITIAL SURGERY DATE OF (B)(6) 2014. THE PATIENT'S SYMPTOMS WERE WOUND DEHISCENCE, LEAKAGE OF WHITISH MATERIAL, SKIN REDNESS, WITH NO PAIN AND NORMAL BLOOD TESTS. THE CAUSE OF THE RESURGERY WAS REPORTED TO BE FROM THE PATIENT REACTION AND PAIN, THE ACL PROCEDURE WAS REPORTED TO BE STILL HOLDING AT THE TIME OF THE RESURGERY ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706935 8MM X 30MM BIOCRYL RAPIDE INTERFERENCE SCREW MITEK ACL IMPLANTS HWC DEPUY MITEK NA 3597014

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R