BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCHOR, PEEK CORKSCREW FT

    MDR report key: 9178714 · Received October 11, 2019

    Report

    Report Number
    1220246-2019-01343
    Event Type
    Injury
    Date Received
    October 11, 2019
    Date of Event
    July 17, 2017
    Report Date
    October 11, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867023666
    PMA / PMN Number
    K061863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PARTS REMAIN IN PATIENT. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PATIENT THROUGH THE ARTHREX WEBSITE THAT THE PATIENT HAD UNDERGONE TENDON REPAIR GLUTEN MEDIUS SURGERY USING ARTHREX ANCHORS IN (B)(6) 2017 (SPECIFIC (B)(6) 2017 DATE NOT PROVIDED IN THE INITIAL REPORT). THE PATIENT INDICATED THAT THE SURGEON HAD USED SUTURE ANCHOR (4.5 MM 2 FT) AND CORKSCREW FIBER WIRE (14 MM). (SPECIFIC ARTHREX PRODUCT NUMBERS WERE NOT PROVIDED IN THE INITIAL REPORT). THE PATIENT STATES THE SURGEON BELIEVES THAT THE PATIENT IS HAVING AN ALLERGIC REACTION TO THE SUTURE MATERIAL ANCHORED IN THE BONES. PATIENT IS REQUESTING MATERIAL COMPOSITION INFORMATION TO BE USED FOR POSSIBLE TESTING FOR HYPERSENSITIVITY/ALLERGIES. PATIENT ALSO STATES THAT PAIN AND INFLAMMATION HAVE CONTINUED. ADDITIONAL INFORMATION OBTAINED 9/16/19: PATIENT HAS PROVIDED THE OPERATIVE REPORT WHICH CONTAINED THE IMPLANT INFORMATION. THE PATIENT HAD RECEIVED THREE IMPLANTS OF THE SAME PART AND LOT NUMBER DURING THE 2017 PROCEDURE. THE PARTS WERE AR-1927PSF-45, CORKSCREW SUTURE ANCHORS, LOT 10113577. PATIENT STATES SHE HAS BEEN IN POST OPERATIVE PAIN THAT NEVER WENT AWAY. PATIENT PARTICIPATED IN OVER ONE YEAR OF PHYSICAL THERAPY SO THE MOBILITY IS THERE BUT STILL LIMITED AND PAINFUL. PATIENT HAS LOCALIZED STIFFNESS AND PAINFUL SWELLING OF THE HIP AREA EVEN WITHOUT EXERCISE. THE PAIN AND STIFFNESS LIMITED GREATLY HER MOBILITY AND PREVENTED HER FROM DOING MORE THAN 20 MINUTES OF AEROBIC EXERCISE (EASY WALKING, SWIMMING, CLIMBING STAIRS). PROLONGED SITTING GREATER THAN 1 HOURS INCREASES THESE SYMPTOMS. PATIENT HAS TRIED PHYSIOTHERAPY, PHYSICAL EXERCISE, STRENGTHENING EXERCISE, NSAID (IN ORAL FORM, PATCHES AND CREAM (NSAID AND USE OF MUSCLE RELAXANTS) AS WELL AS PRESSURE POINT THERAPY (ACUPUNCTURE). NO CULTURES HAVE BEEN TAKEN TO DATE BY ANY PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972517 SUTURE ANCHOR, PEEK CORKSCREW FT SCREW, FIXATION, BONE HWC ARTHREX, INC. SUTURE ANCHOR, PEEK CORKSCREW FT 10113577 00888867023666

    Patients

    Seq Age Sex Outcome Treatment
    1 Other