BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 10801123 · Received November 6, 2020

    Report

    Report Number
    3007420745-2020-00049
    Event Type
    Injury
    Date Received
    November 6, 2020
    Report Date
    November 6, 2020
    Manufacturer
    SYNTHES
    Product Code
    HRS
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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): (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 DIRECTOR OF REGULATORY AFFAIRS 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 10/14/2020, A TRILLIANT SURGICAL SALES REPRESENTATIVE REPORTED AN ALLEGED DEFICIENCY RELATED TO THE ARSENAL SYSTEM'S 330-07-003 (2.2MM ARSENAL SCREW DRIVER BIT) SEEING RETENTION ISSUES BETWEEN THE SCREW HEAD, DRIVER BIT INTERFACE FOLLOWED BY SCREW/PLATE INTERFACE LOCKING ISSUES. THE REPORTED DEFICIENCY OCCURRED DURING A FIFTH METATARSAL REVISION PERFORMED BY DOCTOR 1 AT FACILITY X ON (B)(6) 2020. THE PATIENT INFORMATION IS UNKNOWN AT THIS TIME, BUT FOLLOW UP WITH THE REPRESENTATIVE HAS BEEN MADE (10/15/2020) VIA PHONE TO OBTAIN THE MISSING INFORMATION. DOCTOR 1 PREVIOUSLY IMPLANTED A COMPETITOR'S PLATE TO REPAIR A FIFTH METATARSAL FRACTURE ROUGHLY A YEAR AND A HALF PRIOR TO THIS PROCEDURE. THE PATIENT EXPERIENCED THIS PLATE BREAK AND WAS FOUND TO HAVE FRACTURED THE METATARSAL ONCE AGAIN. DOCTOR 1 SCHEDULED A REVISION PROCEDURE WITH THE INTENTION OF PLATING WITH TRILLIANT'S ARSENAL PLATING SYSTEM TO REDUCE THE FRACTURE ON (B)(6) 2020. DURING THE REVISION PROCEDURE, DOCTOR 1 REDUCED THE FRACTURE FIRST BY IMPLANTING A 2.4MM TIGER CANNULATED SCREW. HE THEN MOVED TO PLATE THE FRACTURE WITH THE SYSTEM'S 300-81-001 (ARSENAL MINI CONDYLAR PLATE, SHORT). WHEN DOCTOR 1 BEGAN TO INSERT THE 2.2MM ARSENAL LOCKING SCREWS TO FIXATE THE PLATE, HE DISCOVERED THAT THE 330-07-003 DRIVER/SCREW HEAD INTERFACE RETENTION WAS POOR. PLEASE NOTE, THE SALES REPRESENTATIVE REPORTED THAT WITH EVERY 2.2MM ARSENAL LOCKING SCREW DOCTOR 1 TRIED, HE ACKNOWLEDGED THE DRIVER HAD POOR RETENTION FOR EACH SCREW. DECIDING TO PROCEED, DOCTOR 1 INSERTED AND LOCKED A 2.2MM ARSENAL LOCKING SCREW INTO THE MOST DISTAL HOLE OF THE 300-81-001 WITHOUT PROBLEM. WHEN HE MOVED TO THE PLATE'S PROXIMAL HOLES, DOCTOR 1 TRIED TO INSERT A 308-22-012 (2.2MM X 12MM ARSENAL LOCKING SCREW) BUT WHEN THE SCREW HEAD REACHED THE PLATE'S LOCKING INTERFACE, THE SCREW JUST SPUN. THE SALES REPRESENTATIVE SAID THE SCREW WAS NOT BEING INSERTED AT AN ANGLE, BUT STRAIGHT ON. THE SAME SCREW WAS INSERTED INTO ANOTHER PROXIMAL HOLE ON THE 300-81-001 PLATE AND DOCTOR 1 EXPERIENCED THE SAME THING, THE SCREW JUST SPUN AND DID NOT LOCK. A DIFFERENT SCREW OF THE SAME SIZE WAS TRIALED AS WELL AS TWO 308-22-014 (2.2MM X 14MM ARSENAL LOCKING SCREW) WITH NO PREVAIL. THE PLATE WAS REMOVED FROM THE FIFTH METATARSAL AND ANOTHER COMPETITOR'S PLATING SYSTEM WAS BROUGHT INTO THE OR TO USE INSTEAD OF THE ARSENAL PLATING SYSTEM. THE AFOREMENTIONED 330-07-003, 300-81-001, (1) 308-22-012 AND (1) 308-22-014 WILL BE RETURNED TO TRILLIANT SURGICAL'S CORPORATE OFFICE FOR FURTHER EVALUATION. (1) 308-22-012 AND (1) 308-22-014 WE DISPOSED OF UPON COMPLETION OF THE CASE BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262982 UNK UNK HRS SYNTHES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention