BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LO-PRO LOCK SCRW TI 4.5X16MM

    MDR report key: 19238604 · Received May 3, 2024

    Report

    Report Number
    1220246-2024-02758
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    April 10, 2024
    Report Date
    September 11, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867124875
    PMA / PMN Number
    K141735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    501

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-8545L-34 SERIAL/BATCH NUMBER UNK WAS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE SCREW IS MISSING ITS ANODIZED COLOR, AND THE HEX GEOMETRY OF THE HEAD HAS BEEN DAMAGED. UPON MEASURING THE SCREW'S OVERALL LENGTH AND OUTSIDE DIAMETER AS PER DRAWING C7252 AT REVISION 4, IT WAS OBSERVED THAT THE SCREW BODY DIAMETER IS SMALLER, WHICH MAY BE ATTRIBUTED TO MATERIAL LOSS FROM BREAKAGE. DIMENSIONAL: OVERALL LENGTH: 1.339 ± .012, 1003729 -CALIPER. MEASUREMENT. 1.341. DIMENSIONAL: MAJOR THREAD DIAMETER: Ø .181+ .000/-.005. 1003783 MICROMETER. MEASUREMENT.: Ø .169. FUNCTIONAL TESTING WAS NOT PERFORMED AS THE DEVICE WAS RECEIVED DAMAGED. THE MOST LIKELY CAUSE(S) FOR THE REPORTED FAILURE CAN BE A USER ERROR DUE TO IMPROPER BONE PREPARATION, MISALIGNED INSERTION, AND/OR PRYING/LEVERING THE DEVICE DURING INSERTION. -DFU-0125-EOR4_FMT_EN. E. WARNINGS. 6. PREOPERATIVE AND OPERATING PROCEDURES, INCLUDING KNOWLEDGE OF SURGICAL TECHNIQUES AND PROPER SELECTION AND PLACEMENT OF THE DEVICE, ARE IMPORTANT CONSIDERATIONS IN THE SUCCESSFUL UTILIZATION OF THIS DEVICE. THE APPROPRIATE ARTHREX DELIVERY SYSTEM IS REQUIRED FOR PROPER IMPLANTATION OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    *** UPDATE DW 01-JUL-2024: FURTHER INFORMATION WAS PROVIDED THAT THE INITIALLY PROVIDED PART NUMBERS WERE INCORRECT. THE CUSTOMER COMPLAINT ONE AR-845L-46, ONE AR-8545L-34 AND ONE AR-8545L-50.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN OSG ARTHRODESE WITH ANKLE FUSION PLATE SYSTEM THE SCREWS PRODUCED DEBRIS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. *** UPDATE DW 17-APR-2024: FURTHER INFORMATION WERE PROVIDED THAT ALL FRAGMENTS WERE RETRIEVED OUT OF THE PATIENT.

    Description of Event or Problem · 0

    *** UPDATE DW 01-JUL-2024: FURTHER INFORMATION WAS PROVIDED THAT THE INITIALLY PROVIDED PART NUMBERS WERE INCORRECT. THE CUSTOMER COMPLAINT ONE AR-845L-46, ONE AR-8545L-34 AND ONE AR-8545L-50.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022220 LO-PRO LOCK SCRW TI 4.5X16MM BONE FIXATION PLATE HRS ARTHREX, INC. LO-PRO LOCK SCRW TI 4.5X16MM UNK 00888867124875

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown