BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.9MM KNOTLESS CORKSCREW, PEEK

    MDR report key: 9179207 · Received October 11, 2019

    Report

    Report Number
    1220246-2019-01350
    Event Type
    Injury
    Date Received
    October 11, 2019
    Date of Event
    September 9, 2019
    Report Date
    October 11, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867270794
    PMA / PMN Number
    K061863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 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 THE PATIENT UNDERWENT A ROTATOR CUFF REPAIR PROCEDURE (DATE OF SURGERY CURRENTLY UNKNOWN). THE PATIENT RE-TORE THEIR ROTATOR CUFF AND HAD A REVISION RCR ON (B)(6) 2019. DURING THE REVISION IT WAS DISCOVERED THAT THE PATIENT'S CUFF WAS IRREPARABLE AND THE SURGEON SWITCHED TO A SUPERIOR CAPSULE RECONSTRUCTION. DUE TO THE SOFT BONE QUALITY THE FOLLOWING ARTHREX PARTS BEING USED WOULD NOT STAY SEATED IN THE BONE: AR-1938BC // LOT: 10265961 // QTY.: 1, AR-1938BC // LOT: F189852 // QTY.: 1. THE REP STATED THE PROCEDURE WAS ARTHROSCOPIC. IT IS UNKNOWN IF ARTHREX PARTS WERE USED DURING THE ORIGINAL RCR; HOWEVER, NO ARTHREX PRODUCTS WERE REMOVED DURING THE REVISION ON (B)(6) 2019. THE REP STATED THERE WERE NO FURTHER ISSUES WITH ANY OTHER ARTHREX PRODUCTS DURING THE CASE. THE HUSBAND OF THE PATIENT CALLED THE SURGEON ON (B)(6) 2019, STATING THE LATERAL PORTAL WOUND WAS DRAINING FLUID AND THEY WERE WORRIED ABOUT INFECTION. THE PATIENT CAME IN FOR A FOLLOW-UP VISIT WITH THE SURGEON ON (B)(6) 2019 TO HAVE THE WOUND LOOKED AT. THE REP STATED THEY CANNOT CONFIRM IF CULTURES WERE TAKEN. AT THE MOMENT NO REVISION PROCEDURE IS SCHEDULED, BUT THE PATIENT HAS BEEN SCHEDULED TO COME BACK FOR A FOLLOW UP VISIT. HOWEVER, THE REP STATED THEY WERE NOT INFORMED OF THE SPECIFIC DATE OF THE FOLLOW-UP, OR GIVEN ANY FURTHER DETAILS. THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED DURING THE (B)(6) 2019 PROCEDURE, AND REMAIN IMPLANTED IN THE PATIENT: AFLEX301 // ID #: 1912747-0106, AR-1938BC // F189852 // QTY.: 1, AR-1941PS // LOT: 10247538 // QTY.: 1, AR-1941PS // LOT: 10248921 // QTY.: 1, AR-3638 // LOT: 10328308 // QTY.: 1. *ADDITIONAL INFORMATION RECEIVED ON 10/04/2019: THE REP REPORTED THERE WAS NO INFECTION FOUND, AND THEY CONTACTED THE MANUFACTURER OF AFLEX301 REGARDING THE MATTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. *ADDITIONAL INFORMATION RECEIVED ON 10/08/2019: THE PATIENT STARTED EXPERIENCING CLEAR DRAINAGE ON (B)(6) 2019. THE PATIENT'S SYMPTOMS WERE TREATED WITH ANTIBIOTICS (CLINDAMYCIN). THE REP CONFIRMED THE GRAFT IMPLANTED (AFLEX301 // ID #: 1912747-0106) WAS PURCHASED BY THE FACILITY DIRECTLY FROM THE MANUFACTURER. IT WAS REPORTED THAT CULTURES WERE NOT TAKEN, AND THERE ARE NO AVAILABLE PICTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972213 3.9MM KNOTLESS CORKSCREW, PEEK SCREW, FIXATION, BONE HWC ARTHREX, INC. 3.9MM KNOTLESS CORKSCREW, PEEK 10247538 00888867270794

    Patients

    Seq Age Sex Outcome Treatment
    1 Other