BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 10851747 · Received November 17, 2020

    Report

    Report Number
    3007420745-2020-00050
    Event Type
    Injury
    Date Received
    November 17, 2020
    Report Date
    November 16, 2020
    Manufacturer
    FLOWER ORTHOPEDICS
    Product Code
    HRS
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    TRILLIANT SURGICAL IS NOT THE MANUFACTURER OF THE SUSPECT MEDICAL DEVICE DISCUSSED. TRILLIANT SURGICAL IS NOT THE MANUFACTURER OF THE HARDWARE THAT WAS REMOVED. 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, THE INVESTIGATION INTO THE REMOVAL IS NOT NECESSARY AND A ROOT CAUSE WILL NOT BE IDENTIFIED REGARDING THE REMOVAL AS IT DOES NOT PERTAIN TO TRILLIANT SURGICAL DEVICES. OTHER THAN THE DETAILS OF THE EVENT THAT WERE PROVIDED AND DOCUMENTED (DESCRIBE EVENT OR PROBLEM), ALL OTHER INFORMATION REGARDING THE DEVICE AND ITS ORIGINAL IMPLANTATION IS UNKNOWN. PER 21CFR803.22(B)(2): 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, DIVISION OF INDUSTRY AND CONSUMER EDUCATION, POST-MARKET BRANCH; (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 10/21/2020, A TRILLIANT SURGICAL SALES REPRESENTATIVE REPORTED AN ALLEGED DEFICIENCY RELATED TO THE ARSENAL FOOT PLATING SYSTEM'S 330-35-001 (3.5MM ARSENAL SCREW DRILL BIT) CUTTING INTO THE CORTEX. THE REPORTED DEFICIENCY OCCURRED DURING A MIDFOOT REVISION PERFORMED BY DOCTOR 1 AT FACILITY X ON (B)(6) 2020. THE PATIENT WAS A(B)(6)-YEAR-OLD (DOB: (B)(6) 1945) MALE, REPORTING AVERAGE WEIGHT, BUT EXACT WEIGHT IS UNKNOWN, WITH GOOD BONE QUALITY. THE PATIENT HAS NO REPORTED COMORBIDITIES AND NO NON-COMPLIANCE WAS REPORTED. THE SALES REPRESENTATIVE CONFIRMED VIA PHONE THAT ALL INFORMATION AVAILABLE REGARDING THE COMPLAINT HAS BEEN PROVIDED. INFORMATION NOT PROVIDED IS NOT AVAILABLE. THIS ACTIVITY CONFIRMS A DILIGENT AND HONEST GOOD FAITH EFFORT HAS BEEN MADE FOR THIS CCR. DOCTOR 1 WAS REVISING A PREVIOUSLY PERFORMED LAPIDUS PROCEDURE, A COMPETITOR'S HARDWARE ORIGINALLY IMPLANTED, AMONG OTHER THINGS WHEN THE CONCERN AROSE REGARDING THE SHARPNESS OF THE 330-35-001. WITH THE ORIGINALLY IMPLANTED HARDWARE REMOVED, DOCTOR 1 WAS REVISING THE FUSION BETWEEN THE FIRST METATARSAL AND MEDIAL CUNEIFORM WITH TRILLIANT'S 300-83-005 (LARGE LAPIDUS PLATE, LEFT), USING THE 3.5MM DIAMETER SCREWS TO SECURE THE PLATE. THE 330-35-006 (3.5MM ARSENAL DRILL SLEEVES) WAS USED IN CONJUNCTION WITH THE 330-35-001, WHICH WAS BEING UTILIZED ON POWER. EACH TIME DOCTOR 1 WENT TO DRILL, THE DRILL WOULD ROTATE ON THE CORTEX FOR 5-10 SECONDS BEFORE GLIDING INTO THE BONE. INCREASED PRESSURE WAS NEEDED AFTER EACH USE. THE SALES REPRESENTATIVE CONFIRMED THAT DOCTOR 1 ONLY USED (1) 330-35-001 THROUGHOUT THE PROCEDURE. THE SALES REPRESENTATIVE OFFERED THE ADDITIONAL DRILLS WITHIN THE TRAY TO SWITCH OUT, BUT DOCTOR 1 OPTED AGAINST IT. THE SALES REPRESENTATIVE AND THE RELATED DISTRIBUTORSHIP AS A WHOLE REPLACE ALL OF THEIR ARSENAL DRILLS AFTER ONE TIME USE AND DID SO, AS NORMAL, BEFORE THIS PARTICULAR CASE SO THE DRILL DID NOT HAVE ANY WEAR FROM BONE PRIOR TO THIS OCCURRENCE. THE SALES REPRESENTATIVE REPORTED THE "DULL" DRILLS ARE CONTINUOUS OCCURRENCE WHEN USING THE 330-35-001, HAPPENING ABOUT 75% OF THE CASES COVERED. DOCTOR 1 NOTED TO THE SALES REPRESENTATIVE THAT WHEN USING OTHER VENDOR'S DRILLS, THEY JUST GLIDE INTO THE BONE, NO ADDITIONAL PRESSURE OR TIME ROTATING BEFORE CUTTING THROUGH THE CORTEX IN ORDER TO OBTAIN THE PREPARATION HE NEEDS. THE 330-35-001 USED WILL NOT BE RETURNING TO TRILLIANT SURGICAL'S CORPORATE OFFICE FOR FURTHER INVESTIGATION. IT'S BEEN REQUESTED OF THE SALES REPRESENTATIVE AND THE RELATED TEAM TO KEEP A PARTICULAR WATCH OUT FOR ANY MORE INSTANCES THEY ARE EXPERIENCING DRILL CONCERNS AND TO ENSURE THEY COLLECT THE DRILLS AFTER USE FOR FORMAL INVESTIGATION, OR AT THE VERY LEAST THE LOT NUMBERS OF THE DRILLS UTILIZED. TRILLIANT SURGICAL'S SENIOR VICE PRESIDENT OF SALES HAS REQUESTED FOLLOW UP REGARDING THE INVESTIGATION OF THIS PARTICULAR REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317908 UNK UNK HRS FLOWER ORTHOPEDICS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention