BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE ANCHOR, PUSHLOCK 3.5 X 19.5MM

    MDR report key: 7902505 · Received September 24, 2018

    Report

    Report Number
    1220246-2018-00669
    Event Type
    Injury
    Date Received
    September 24, 2018
    Date of Event
    September 7, 2018
    Report Date
    September 24, 2018
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867023338
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    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 THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE EXPLANTED DEVICE WAS REPORTED TO HAVE BEEN DISCARDED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. A POSSIBLE CAUSE OF THIS TYPE OF EVENT MAY BE A REACTION OF THE PATIENT TO THE MATERIAL(S) IMPLANTED OR USED DURING THE IMPLANT PROCEDURE. PRODUCT DIRECTIONS FOR USE WARNS OF EFFECTS LIKE FOREIGN BODY AND ALLERGIC-LIKE REACTIONS AS WELL AS INFECTIONS BOTH DEEP AND SUPERFICIAL TO THE IMPLANT MATERIALS. PATIENT SENSITIVITY TO MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION.

    Description of Event or Problem · 1

    AN INITIAL CONTACT WAS RECEIVED THROUGH THE ARTHREX WEBSITE REQUESTING A CONTACT PERSON REGARDING POST-OPERATIVE INFECTIONS INVOLVING ARTHREX PRODUCTS. UPON FURTHER INVESTIGATION IT HAS BEEN DISCOVERED THAT A PATIENT HAD LEFT SHOULDER ARTHROSCOPY-ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2018. DURING THE PROCEDURE THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: ARTHREX SUTURE ANCHOR PEEK CORKSCREW FT 4.5X14MM X2(AR-1927PSF-45, LOT: F200079 AND LOT: F185845) AND SUTURE ANCHOR PUSHLOCK 3.5X19.5MM X3(AR-1926PS, LOT: 10194738). DURING PATIENT OFFICE VISIT ON (B)(6) 2018 PATIENT REPORTED POSSIBLE REACTION TYPE SYMPTOM. THE SYMPTOMS INCLUDED: ERYTHEMA, PAIN AND TENDERNESS. THE PATIENT HAS BEEN TREATED WITH PO ANTIBIOTICS, AND SURGERY TO DRAIN SHOULDER AND REMOVE ALL IMPLANTS EXCEPT FOR TWO PUSHLOCK ANCHORS. TESTING HAS BEEN PERFORMED HOWEVER TO DATE ALL CULTURES HAVE BEEN REPORTED AS NEGATIVE, INCLUDING P-ACNES. ADDITIONAL INFORMATION OBTAINED 9/11/2018: THE DATE OF THE SECOND SURGERY TO DRAIN SHOULDER AND REMOVE ALL IMPLANTS EXCEPT FOR TWO PUSHLOCK ANCHORS WAS (B)(6) 2018. THE SURGERY WAS PERFORMED AT A DIFFERENT FACILITY THAN THE ORIGINAL PROCEDURE. THE EXPLANTED ANCHORS ARE REPORTED TO HAVE BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745302 SUTURE ANCHOR, PUSHLOCK 3.5 X 19.5MM SCREW, FIXATION, BONE LXH ARTHREX, INC. SUTURE ANCHOR, PUSHLOCK 3.5 X 19.5MM 10194738 00888867023338

    Patients

    Seq Age Sex Outcome Treatment
    1 Other