BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCHOR, BIO- PUSHLOCK, 3.5MM

    MDR report key: 2103583 · Received May 26, 2011

    Report

    Report Number
    1220246-2011-00086
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K061863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD 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 CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DISCARDED BY FACILITY.

    Description of Event or Problem · 1

    SIGNIFICANT INFECTION AFTER (B)(6) POST OP. DOS WAS (B)(6) 2011. ROTATOR CUFF REPAIR. (B)(6) POST-OP, PATIENT REPORTED PAIN AT INSERTION SITE, INFECTION. FIRST SEEN FOR FLUSHING OF INFECTED WOUND ON (B)(6) 2011. ON (B)(6) 2011, SURGEON REMOVED IMPLANTS AND ALL SUTURES. PATIENT`S CUFF WAS HEALED SO NO ADDITIONAL IMPLANTS WERE NEEDED. PATIENT TREATED WITH ANTIBIOTIC BEADS IN WOUND. BLOOD AND WOUND CULTURES WERE NEGATIVE SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURE ANCHOR, BIO- PUSHLOCK, 3.5MM SCREW, FIXATION, BONE HWC ARTHREX, INC. 265337

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other (B)(4) LOT 389622