BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 10554509 · Received September 18, 2020

    Report

    Report Number
    3007420745-2020-00038
    Event Type
    Injury
    Date Received
    September 18, 2020
    Report Date
    August 21, 2020
    Manufacturer
    UNK
    Product Code
    HWC
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. PER 21CFR803.22 (B)(2): (B) YOU ARE NOT REQUIRED TO SUBMIT A MEDICAL DEVICE REPORT IF: (2) 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 (B)(6) CONTACTED THE FDA BY PHONE AT THE NUMBER (B)(6). SHE WAS CONNECTED TO (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 (B)(6) 2020, A TRILLIANT SURGICAL SALES REPRESENTATIVE REPORTED AN ALLEGED DEFICIENCY RELATED TO THE PERFORMANCE OF A 330-07-003 (2.2MM ARSENAL SCREW DRIVER BIT) BREAKING INTRAOPERATIVELY. THE REPORTED DEFICIENCY OCCURRED DURING A MIDFOOT FUSION REVISION PERFORMED BY DOCTOR 1 AT FACILITY X ON (B)(6) 2020. THE PATIENT WAS A (B)(6)-YEAR-OLD (DOB:(B)(6)) FEMALE, WEIGHT UNKNOWN, WITH REPORTED GOOD BONE QUALITY. THE PATIENT DID NOT HAVE ANY 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 PERFORMING A REVISION ON A PREVIOUSLY COMPLETED MIDFOOT FUSION DUE TO REPORTED PATIENT PAIN CAUSED BY BROKEN SCREWS. THE ORIGINAL FUSION WAS PERFORMED TWO YEARS PRIOR BY ANOTHER DOCTOR WITH ANOTHER COMPANY, HARDWARE COMPANY IS UNKNOWN. DOCTOR 1 WAS USING THE ARSENAL PLATING SYSTEM'S 210-00-004 (RATCHETING HANDLE), WHICH HE USED IN CONJUNCTION WITH THE 330-07-003 DRIVER WHILE INSERTING ALL SCREWS IN THIS REPORT. AFTER REMOVING THE OLDER HARDWARE, DOCTOR 1 WAS IMPLANTING A 300-81-001 (ARSENAL MINI CONDYLAR PLATE, SHORT) ON THE THIRD CUNEIFORM WHEN HE EXPERIENCED THE 330-07-003 BREAK. THE SALES REPRESENTATIVE REPORTED THE SCREW WAS NOT FULLY INSERTED/LOCKED INTO THE PLATE, BUT BELIEVES THE SCREW WAS INSERTED BICORTICALLY WHEN THE TIP OF THE 330-07-003 BROKE. THE SURGICAL SITE WAS CLEARED OF DEBRIS AND RINSED, THEN CONFIRMED UNDER FLUOROSCOPY THE SITE WAS CLEARED BEFORE CONTINUING. THE SECONDARY 330-07-003 THAT IS PROVIDED IN THE SYSTEM WAS USED TO CONTINUE IMPLANTATION. THE CASE WAS COMPLETED WITHOUT FURTHER ISSUE, AND DOCTOR 1 WAS HAPPY WITH THE OUTCOME. THE 330-07-003 WILL BE RETURNED TO TRILLIANT SURGICAL'S CORPORATE OFFICE FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020778 UNK UNK HWC UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention