BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONSTER SCREW SYSTEM

    MDR report key: 18059901 · Received November 2, 2023

    Report

    Report Number
    3008650117-2023-00113
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Date of Event
    October 12, 2023
    Report Date
    January 29, 2025
    Manufacturer
    PARAGON28, INC
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. POTENTIAL CAUSE: CYCLICAL USE OF THIS INSTRUMENT WITH APPLICATION TO HARD BONE CAUSED THE TAP TO BREAK.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4, UDI.

    Additional Manufacturer Narrative · 0

    PRODUCT EVALUATION: THE TAP IS DISPOSITIONED AS SCRAP AS IT IS NOT UNUSABLE FOR ITS INTENDED PURPOSES FOLLOWING THIS PROCEDURE. THE THREADED PORTION OF THE SCREW TAP WAS NOT RETURN WITH THE REST OF THE TAP. THE THREADED PORTION BROKE ABOUT 2-3 MM INTO THE THREADING. THE HAMMERTUBE SYSTEM DOES NOT COME WITH A P20-920-3000 SCREW TAP. ADDITIONALLY, THE HAMMERTUBE SURGICAL TECHNIQUE GUIDE FOR THE SYSTEM DOES NOT CALL OUT THE USE OF A MONSTER SCREW TAP. POTENTIAL CAUSE: CYCLICAL USE OF THIS INSTRUMENT WITH APPLICATION TO HARD BONE CAUSED THE TAP TO BREAK. THIS INSTRUMENT IS NOT INTENDED TO BE USED WITH THE HAMMERTUBE SYSTEM PER THE STG. DHR REVIEW: THE DHR WAS REVIEWED AND THERE ARE NO INDICATIONS OF MANUFACTURING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED THAT CHANGES THE INFORMATION PROVIDED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    CORRECTION: D4, UDI.

    Description of Event or Problem · 0

    THE TIP OF THE TAP BROKE OFF IN THE PROXIMAL PHALANX WHEN ATTEMPTING TO INSERT THE TAP DURING A HAMMERTOE CORRECTION ON THE 4TH DIGIT AND WAS LEFT IN THE PATIENT.

    Description of Event or Problem · 0

    THE TIP OF THE TAP BROKE OFF IN THE PROXIMAL PHALANX WHEN ATTEMPTING TO INSERT THE TAP DURING A HAMMERTOE CORRECTION ON THE 4TH DIGIT AND WAS LEFT IN THE PATIENT.

    Description of Event or Problem · 0

    THE TIP OF THE TAP BROKE OFF IN THE PROXIMAL PHALANX WHEN ATTEMPTING TO INSERT THE TAP DURING A HAMMERTOE CORRECTION ON THE 4TH DIGIT AND WAS LEFT IN THE PATIENT.

    Description of Event or Problem · 0

    THE TIP OF THE TAP BROKE OFF IN THE PROXIMAL PHALANX WHEN ATTEMPTING TO INSERT THE TAP DURING A HAMMERTOE CORRECTION ON THE 4TH DIGIT AND WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349973 MONSTER SCREW SYSTEM 3.0MM MINI MONSTER TAP LXH PARAGON28, INC P20-920-3000 PEN31253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male