BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACU-LOC® WRIST SPANNING PLATE, SHORT

    MDR report key: 17822323 · Received September 26, 2023

    Report

    Report Number
    3025141-2023-00487
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    September 3, 2023
    Report Date
    September 26, 2023
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K131380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PLATE ACU-LOC® WRIST SPANNING PLATE, SHORT (PART NUMBER 7006-1170N-S, BATCH 587682) INVOLVED IN THIS EVENT WAS NOT RETURNED. MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. HOWEVER, THE SCREW 2.7MM X 12MM NL HEXALOBE COCR SCREW (PART NUMBER 3061-27012, BATCH NUMBER 585576) AND THE DRILL 2.0MM QUICK RELEASE DRILL (PART NUMBER 80-0318, BATCH NUMBER 568732) INVOLVED IN THIS EVENT WERE RETURNED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. THE PRODUCT WAS VISUALLY INSPECTED UNDER MAGNIFICATION TO CONFIRM FAILURE. UNDER MAGNIFICATION THE SCREW BATCH NUMBER WAS IDENTIFIED AS 585576. THE RETURNED SCREW MEASURED AT .1685"/4.279MM OF THE TOTAL .562"/14.278MM. PER A CONVERSATION WITH THE SURGEON, "THE SCREW BROKE DURING INSERTION". THE FRACTURE PATTERN SHOWED SIGNS OF A SHEAR FORCE BREAK. THIS WAS CONSISTENT WITH THE SCREW BEING ROTATED WITH ENOUGH TORQUE TO BE BROKEN. THE DRILL (PART NUMBER 80-0318, BATCH NUMBER 568732) WAS ALSO RETURNED TO CONFIRM IF THE PILOT DIAMETER WAS FACTORED. THE DRILL OUTER DIAMETER WAS MEASURED TO BE .0775" WHICH UNDER MMC (MAXIMUM MATERIAL CONDITION) OF THE SCREW'S MINOR DIAMETER DID NOT HAVE AN INTERFERENCE FIT. HOWEVER, BASED ON THE INFORMATION RECEIVED THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A SURGERY, THE SURGEON WAS ATTEMPTING TO PUT IN THE NON-LOCKING COBALT CHROME SCREW INTO THE METACARPAL BONE AND THE SCREW SNAPPED OFF NEAR THE HEAD BEFORE IT WAS COMPLETELY SAT DOWN AGAINST THE PLATE. IT WAS ALSO REPORTED DRILL WAS NOT DAMAGED, AND THE SCREW FRAGMENTS WERE RETRIEVED. THE SURGEON USED REGULAR TITANIUM SCREWS TO COMPLETE THE PROCEDURE WITH NO DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THIS REPORT IS RELATED TO REPORT NUMBER 3025141-2023-00488 AND 3025141-2023-00489 FOR THE SCREW AND DRILL INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972913 ACU-LOC® WRIST SPANNING PLATE, SHORT PLATE, FIXATION, BONE HRS ACUMED LLC 7006-1170N-S 587682

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male