BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM

    MDR report key: 9985407 · Received April 22, 2020

    Report

    Report Number
    1220246-2020-01800
    Event Type
    Injury
    Date Received
    April 22, 2020
    Date of Event
    January 7, 2020
    Report Date
    May 12, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    UDI-DI
    00888867251236
    PMA / PMN Number
    K191226
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL SUBMISSION IS TO CORRECT THE DEVICE PART NUMBER FROM THE ORIGINAL SUBMISSION (1220246-2020-1800) TO REFLECT THE NEW DEVICE PART NUMBER OF AR-2323BCC, WITH A DEVICE PRODUCT CODE OF MAI WITH A 510(K) OF K191226 AND UDI #(B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED: RECEIVED CONFIRMATION FROM FACILITY THAT THE ORIGINAL PART NUMBERS PROVIDED WERE INCORRECT. THE PART NUMBERS HAVE BEEN CHANGED TO THE CORRECT PRODUCT (AR-2323BCC / LOT: 10268328 AND AR-2324BCC / LOT: 10431237).

    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 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 THAT A PATIENT UNDERWENT A SHOULDER REPAIR SURGERY ON (B)(6) 2020 IN WHICH AR-2324BCT-2 & AR-2323BCT-2 WERE IMPLANTED. THE PATIENT HAS BEEN EXPERIENCING POST-OP SYMPTOMS OF REDNESS, SWELLING AND DRAINING. THE PATIENT HAS BEEN REFERRED TO AN IMMUNOLOGIST. THE IMMUNOLOGIST IS REQUESTING SAMPLE PRODUCT OF AR-2324BCT-2 & AR-2323BCT-2. THE IMMUNOLOGY APPOINTMENT IS SCHEDULED FOR (B)(6) 2020. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 4/01/2020: THE ORIGINAL PROCEDURE PERFORMED WAS A LEFT ROTATOR CUFF REPAIR (TWO ANCHORS SUTURE BRIDGE) SUBACROMIAL DECOMPRESSION AND SUB PECTORALIS BICEPS TENODESIS. THE FACILITY REPORTED AR-2324BCT-2 (LOT: 10431237) & AR-2323BCT-2 (LOT: 10268328) WERE THE ONLY ARTRHEX PRODUCTS IMPLANTED DURING THE PROCEDURE. THE PATIENT'S SYMPTOMS FIRST STARTED ON (B)(6) 2020. POSTOPERATIVELY, THE PATIENT DEVELOPED CELLULITIS OVERLYING THEIR LEFT SHOULDER AND UPPER ARM. THE PATIENT WAS INITIALLY PLACED ON KEFLEX WHICH DID NOT SEEM TO IMPROVE THEIR SYMPTOMS AND WAS THEN TRANSITIONED TO CLINDAMYCIN AGAIN WITH NO SIGNIFICANT CHANGES. THE PATIENT WAS THEN REFERRED TO INFECTIOUS DISEASE WHO STARTED THEM ON IV VANCOMYCIN. AGAIN THERE WAS NO SIGNIFICANT CHANGES IN THEIR SYMPTOMS. AN MRI WITH AND WITHOUT CONTRAST WAS OBTAINED TO THE LEFT SHOULDER THAT DEMONSTRATED SOME FLUID WITHIN THE SUBACROMIAL SPACE AND SURGICAL FIELD AND ASSOCIATED BONY EDEMA. THE MRI WAS INCONCLUSIVE FOR INFECTION VERSUS STANDARD POSTOPERATIVE CHANGES. AN ASPIRATION WAS PERFORMED OF THE SUBACROMIAL SPACE WHICH ON EXTENDED FINAL CULTURES WAS NEGATIVE. DUE TO THE PATIENT'S HISTORY OF MULTIPLE INFECTIONS AFTER OTHER SURGERIES AND PERSISTENT SYMPTOMS WITH THE LEFT SHOULDER GIRDLE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2020 FOR LEFT SHOULDER ARTHROSCOPIC I&D, CULTURES AND TISSUE BIOPSIES. EXTENDED FINAL CULTURES AND TISSUE BIOPSIES FROM THE PATIENT'S REPEAT SURGICAL INTERVENTION WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448961 BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. AR-2323BCC 10268328 00888867251236

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other