BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAL SCREW, TI, 1.6 X 10MM

    MDR report key: 11046363 · Received December 21, 2020

    Report

    Report Number
    1220246-2020-02413
    Event Type
    Injury
    Date Received
    December 21, 2020
    Date of Event
    November 17, 2020
    Report Date
    December 21, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867313675
    PMA / PMN Number
    K191326
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT HAND ORIF OF 4TH AND 5TH METACARPAL FRACTURES PROCEDURE THE SURGEON WAS USING THE ARTHREX MINI COMPREHENSIVE FIXATION SYSTEM AR-18700FS. WHEN SURGEON WAS REDUCING THE 4TH METACARPAL FX THE POINT-TO-POINT CLAMP TIPS ON THE AR-18700-45 BENT. ANOTHER ISSUE OCCURRED WHEN HE WAS PLATING THE 5TH METACARPAL LATER IN THE CASE. HE WAS USING THE DEPTH GAUGE AR-18700-27 (FROM THE AR-18700FS) TO MEASURE THE LENGTH OF THE SCREW AND THE DEPTH GAUGE PIN ASSEMBLY BENT IN MULTIPLE DIRECTIONS. THERE WAS ANOTHER ISSUE WITH TWO OF THE VAL 1.6MM SCREWS THAT WERE PLACED IN THE PLATE LOCATED ON THE 5TH METACARPAL. WHEN ADVANCING A 1.6 X 09MM SCREW, AR-18716V-09, THE SCREW HEAD SNAP OFF THE SCREW BEFORE THE THREADS OF THE LOCKING HAD EVER ENGAGED WITH THE PLATE. THIS HAPPENED IN THE EXACT SAME WAY WITH A 1.6 X 10MM SCREW, AR-18716V-10. THE SCREW THREADS THAT HAD MADE IT THROUGH THE PLATE AND THAT WERE ADVANCED INTO THE BONE WERE LEFT IN THE PATIENT'S BONE. ADDITIONAL INFORMATION OBTAINED 11/30/2020: THE AR-18700-45 AND AR-18700-27 WERE FROM THE AR-18700FS INSTRUMENT SET. THE TWO INSTRUMENTS WILL BE RETURNED FOR EVALUATION. THE PROXIMAL ENDS OF THE AR-18716V-09 AND AR-18716V-10 WERE BOTH DISPOSED OF AT THE TIME OF PROCEDURE. TO PREP THE BONE SOCKET FOR INSERTION OF THE SCREWS THE SURGEON USED AND AR-18700-12 (1.2MM DRILL BIT). THE PATIENT BONE QUALITY WAS REPORTED TO BE GOOD. THIS WAS A REVISION PROCEDURE SO THE BONE WAS HEALING FOR 2 MONTHS WHEN THE PATIENT FRACTURED IT AGAIN. THE PATIENT STILL HAD BONE CALLUS FROM THE PREVIOUS INJURY. ADDITIONAL INFORMATION OBTAINED 12/1/2020: THE PATIENT'S ORIGINAL PROCEDURE WAS PERFORMED AT A DIFFERENT FACILITY AND THE DATE OF THE ORIGINAL PROCEDURE IS UNKNOWN. DURING THE ORIGINAL PROCEDURE A 3.5 HEADLESS CANNULATED SCREW (AR-8730-XX / LENGTH UNKNOWN) WAS IMPLANTED. THE ORIGINAL PROCEDURE WAS AN INTERMEDULLARY SCREW FIXATION OF THE 5TH METACARPAL NECK FRACTURE. DURING THE REVISION THE SURGEON ATTEMPTED TO EXPLANT THE ORIGINAL SCREW BUT WAS UNABLE TO EXTRACT IT FROM THE 5TH METACARPAL BONE. THE SCREW WAS LEFT IN AND THE PLATE WAS PLACED OVER THE TOP OF THE INTERMEDULLARY SCREW IN THE 5TH METACARPAL. SCREWS WERE PLACED AROUND THE INTERMEDULLARY SCREW, FIXATING THE PLATE TO THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514373 VAL SCREW, TI, 1.6 X 10MM PLATE, FIXATION, BONE HRS ARTHREX, INC. VAL SCREW, TI, 1.6 X 10MM 047411944 00888867313675

    Patients

    Seq Age Sex Outcome Treatment
    1 Other