BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, ROUND DELTA TAPE- RED INTERFER 10 X 35MM

    MDR report key: 3082018 · Received April 29, 2013

    Report

    Report Number
    1220246-2013-00064
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    December 13, 2012
    Report Date
    April 3, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K062466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. 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. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT; NO ISSUES WERE FOUND WITH THE STERILIZATION OF THIS LOT. THIS DEVICE IS SUPPLIED STERILE. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE POST-OPERATIVE INFECTION COULD NOT BE DETERMINED. THE MOST LIKELY CAUSE FOR THIS TYPE OF EVENT IS A NOSOCOMIAL SOURCE OR PATIENT NON-COMPLIANCE WITH POST-OP WOUND CARE DIRECTIONS. 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. DISCARDED BY THE FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SURGERY INVOLVING AN AR-5035P-10, PATIENT CAME DOWN WITH AN INFECTION DUE TO STAPHYLOCOCCUS AUREUS BACTERIA. THE INFECTION OCCURRED TWO MONTHS POST-OP. THE PATIENT WAS TREATED WITH I&D, ARTHROSCOPIC LAVAGE, HARDWARE REMOVAL THEN ANTIBIOTICS. NO CANNULA WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184855 SCREW, ROUND DELTA TAPE- RED INTERFER 10 X 35MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 330103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other