BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRV SFT,CANN,QC,T15 HEXALOBE

    MDR report key: 17824949 · Received September 27, 2023

    Report

    Report Number
    1220246-2023-07991
    Event Type
    Injury
    Date Received
    September 27, 2023
    Date of Event
    August 29, 2023
    Report Date
    July 10, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MDM
    UDI-DI
    00888867052222
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H6. THE COMPLAINT ALLEGATION IS NOT CONFIRMED. THE DEVICE WAS NOT RECEIVED FOR EVALUATION. NO PICTURES WERE SUBMITTED. THE BONE QUALITY ENCOUNTERED DURING THE PROCEDURE WERE NOT PROVIDED. THE MOST LIKELY CAUSE CAN BE ATTRIBUTED MISUSE DUE TO IMPROPER BONE PREPARATION; MISALIGNED INSERTION; OR PRYING/LEVERAGING THE SCREW DURING INSERTION.

    Additional Manufacturer Narrative · 0

    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. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 30TH AUGUST 2023, IT WAS REPORTED BY A SALES REP VIA EMAIL CONCERNING 2 PIECES OF AR-8840C-45, LOW PROFILE SCREW¿, SS, 4.0 X 45 MM, CANNULATED, SHORT THREAD. FOR 1 OF THE AR-8840C-45, ITS SCREW HEAD WAS STRIPPED. BOTH WERE EVENTUALLY REMOVED FROM THE PATIENT DUE TO REDUCTION LOSS. THIS OCCURRED DURING A LEFT OPEN REDUCTION INTERNAL FIXATION ANKLE FRACTURE PROCEDURE ON (B)(6) 2023. AS PART OF A LEFT ANKLE ORIF (ALSO INCLUDING PLATE AND SYNDESMOSIS TIGHTROPES), SURGEON ATTEMPTED TO INSERT 2X 4.0MMX 45MM SHORT-THREAD CANNULATED SCREWS AR-8840C-45 INTO THE MEDIAL SIDE OF THE ANKLE. PER TECHNIQUE, THE SURGEON FIRST USED 1.35MM GUIDE WIRE AR-8943-01, GUIDE WIRE, TROCAR TIP, 1.35 MM X 130 MM, THEN OVERDRILLED WITH A AR-8943-02, DRILL BIT, CANNULATED, 2.6 MM. WHEN INSERTING THE SCREW USING THE AR-8943-12, DRIVE SHAFT, CANNULATED, QC, T15 HEXALOBE PER SURGICAL TECHNIQUE, THE SURGEON STATED THAT SHE WAS UNABLE TO ADVANCE THE SCREW PROPERLY AS THE DRIVER SHAFT WAS NOT ENGAGING PROPERLY WITH THE SCREW. FOR THE SECOND IDENTICAL SCREW, THE SURGEON SWITCHED TO THE AR-8943-09, SCREWDRIVER, T15 HEXALOBE, CANNULATED AND THE SURGEON STATED THAT THIS SCREW ADVANCED MORE SUCCESSFULLY. UPON IMAGING, THE SURGEON THEN REMOVED BOTH SCREWS AND STATED THAT SHE HAD LOST REDUCTION DUE TO THE FIRST DRIVER SHAFT NOT ENGAGING PROPERLY. THE SURGEON ALSO STATED THAT THE FIRST SCREW HEAD WAS STRIPPED DUE TO THE FIRST DRIVER SHAFT NOT ENGAGING PROPERLY. THE SURGEON DECIDED TO ABORT INSERTING SCREWS INTO THE MEDIAL SIDE OF THE ANKLE AS THE PATIENT WAS TOO SWOLLEN TO CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441161 DRV SFT,CANN,QC,T15 HEXALOBE MANUAL INSTR, GENERAL SURGICAL MDM ARTHREX, INC. DRV SFT,CANN,QC,T15 HEXALOBE UNK 00888867052222

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other