BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.3 X 3.8MM HAMMERTOE IMPLANT AND 4.3 X 2.8MM HAMMERTOE IMPLANT

    MDR report key: 9759478 · Received February 26, 2020

    Report

    Report Number
    3007420745-2020-00015
    Event Type
    Injury
    Date Received
    February 26, 2020
    Report Date
    July 29, 2019
    Manufacturer
    STAYFUSE
    Product Code
    HWC
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TRILLIANT SURGICAL IS NOT THE MANUFACTURER OF THE SUSPECT MEDICAL DEVICE DISCUSSED. UPON RECEIVING ADDITIONAL INFORMATION FROM THE INITIAL REPORTER, IT WAS IMMEDIATELY CONFIRMED THAT PRODUCT IN QUESTION WAS NOT MANUFACTURED BY TRILLIANT SURGICAL OR DISTRIBUTED BY TRILLIANT SURGICAL. THE PROVIDED FEEDBACK DOES NOT ALLEGE A DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF A TRILLIANT SURGICAL DEVICE, NOR DOES THE FEEDBACK, AS PROVIDED, ALLEGE FAILURE OF A TRILLIANT SURGICAL DEVICE OR ITS LABELING OR PACKAGING TO MEET ITS SPECIFICATIONS. AS A RESULT, AN INVESTIGATION WAS NOT CONDUCTED. YOU ARE NOT REQUIRED TO SUBMIT A MEDICAL DEVICE REPORT IF: YOU ARE A MANUFACTURER OR IMPORTER AND YOU DID NOT MANUFACTURE OR IMPORT THE DEVICE ABOUT WHICH YOU HAVE ADVERSE EVENT INFORMATION. WHEN YOU RECEIVE REPORTABLE EVENT INFORMATION IN ERROR, YOU MUST FORWARD THIS INFORMATION TO US WITH A COVER LETTER EXPLAINING THAT YOU DID NOT MANUFACTURE OR IMPORT THE DEVICE IN QUESTION. TO UNDERSTAND HOW TRILLIANT SURGICAL SHOULD FORWARD INFORMATION TO THE FDA WITH A COVER LETTER AS STATED IN 21CFR803.22(B)(2), TRILLIANT SURGICAL'S DIRECTOR OF REGULATORY AFFAIRS CONTACTED THE FDA BY PHONE AT THE NUMBER (B)(6). SHE WAS CONNECTED TO (B)(6) (CONSUMER SAFETY OFFICER, (B)(6) WHO ADVISED THAT, IN ORDER TO SATISFY THE REGULATION STATED ABOVE, A TRILLIANT SURGICAL REPRESENTATIVE SHOULD COMPLETE FORM 3500A BY PROVIDING ANY INFORMATION THAT WAS OBTAINED AND QUOTE THE REGULATION.

    Description of Event or Problem · 1

    ON THE EVENING OF (B)(6) 2019, DOCTOR 1 EMAILED (B)(6) REQUESTING GUIDANCE ON REMOVING TWO (2) HAMMERTOE IMPLANTS, BELIEVED TO BE TRILLIANT SURGICAL IMPLANTS, IN AN UPCOMING CASE. DOCTOR 1 WAS CALLED THE MORNING OF (B)(6) 2019 TO COLLECT MORE INFORMATION ABOUT THE REMOVAL. THE HAMMERTOE IMPLANTS WERE ORIGINALLY IMPLANTED ON (B)(6) 2010 BY DOCTOR 2 DURING A 2ND AND 3RD PIP ARTHRODESIS PROCEDURE. THE PATIENT (FEMALE, AGE UNKNOWN) EXPERIENCED A MINOR TRAUMA BY STUBBING HER 2ND DIGIT AGAINST A POST RESULTING IN A PHALANGEAL FRACTURE. DUE TO THE NATURE OF THE FRACTURE, DOCTOR 1 DECIDED IT WOULD BE BEST TO REMOVE THE IMPLANT TO ALLOW PROPER TREATMENT. DOCTOR 1'S SURGICAL PLAN WAS TO REMOVE THE 2ND DIGIT IMPLANT AND LEAVE THE 3RD DIGIT IMPLANT UNTOUCHED. IT SHOULD BE NOTED THAT THE 3RD DIGIT IMPLANT WAS IDENTIFIED AS BROKEN THROUGH X-RAYS. THIS OCCURRED SHORTLY AFTER ITS ORIGINAL IMPLANTATION DUE TO PATIENT NONCOMPLIANCE WITH EARLY AMBULATION. AFTER THIS INFORMATION WAS COLLECTED FROM DOCTOR 1, IT WAS SUSPECTED THAT, DUE TO THE ORIGINAL DATE OF THE IMPLANTATION AND THE IMPLANT SIZES PROVIDED (4.3 X 3.8MM AND 4.3 X 2.8MM), THE IMPLANTS COULD NOT HAVE BEEN MANUFACTURED BY TRILLIANT SURGICAL. TRILLIANT SURGICAL'S VICE PRESIDENT OF SALES WAS ABLE TO DETERMINE VIA X-RAY THAT THE IMPLANTS WERE MANUFACTURED BY STAYFUSE. TRILLIANT SURGICAL WAS ABLE TO PROVIDE DOCTOR 1 WITH RECOMMENDATIONS TO HELP HIM IN HIS UPCOMING CASE AND NO FURTHER ACTION WAS TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218106 4.3 X 3.8MM HAMMERTOE IMPLANT AND 4.3 X 2.8MM HAMMERTOE IMPLANT STAYFUSE HAMMERTOE IMPLANT HWC STAYFUSE UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention