BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARALLEL PIN GUIDE, BULLET NOSE, 3.2MM

    MDR report key: 21949511 · Received May 2, 2025

    Report

    Report Number
    1220246-2025-01848
    Event Type
    Malfunction
    Date Received
    May 2, 2025
    Date of Event
    April 9, 2025
    Report Date
    June 20, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    UDI-DI
    00888867521698
    PMA / PMN Number
    K014185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H1, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED 0322-000 BULLET NOSE, 3.2MM PARALLEL PIN GUIDE (PART OF THE 9913-000 7.0MM CANNULATED SCREW SYSTEM CASE) BATCH NUMBER: 240504 WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE NOTED THAT A K-WIRE WAS STUCK WITHIN ONE OF THE HOLES OF THE 0322-000 BULLET NOSE, 3.2MM PARALLEL PIN GUIDE. FURTHER VISUAL EVALUATION NOTED DAMAGE TO THE SURFACE OF THE DEVICE AND IT WAS NOTED THAT THE K-WIRE WAS BENT AND DAMAGED WITHIN THE DEVICE. FUNCTIONAL TESTING WAS NOT ABLE TO BE PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO PRYING/LEVERAGING THE MATING K-WIRE DEVICE DURING USE. REFER TO INVESTIGATION PHOTOS. CORRECTION: H1 TO N/A. ARTHREX PREVIOUSLY SUBMITTED THIS EVENT AS A REPORTABLE MALFUNCTION OUT OF AN ABUNDANCE OF CAUTION. UPON RECEIVING ADDITIONAL INFORMATION THAT CLARIFIED THE EVENT, IT HAS BEEN DETERMINED THAT THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER 21 CFR 803.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B3, B5, H3, H6.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 05/28/2025: THIS ISSUE OCCURRED OUTSIDE THE PATIENT DURING USE. THE GUIDE MALFUNCTIONED EXTERNALLY, AND THE WIRE STUCK ON THE SKIN'S SURFACE RATHER THAN INSIDE THE PATIENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 05/01/2025: ON (B)(6)2025, A CLOSED REDUCTION PERCUTANEOUS PINNING OF A HIP FRACTURE WAS PERFORMED. THE PROCEDURE WAS COMPLETED USING A FREEHAND TECHNIQUE, UTILIZING A SINGLE-HOLE PIN GUIDE FOR K-WIRES RATHER THAN A BULLET NOSE GUIDE. THE CASE WAS COMPLETED USING THE SINGLE GUIDE: 0615-000 SHEATH WITH 0319-000 PIN GUIDE. A BRIEF DELAY OF APPROXIMATELY 2-3 MINUTES OCCURRED WHILE ATTEMPTING TO REMOVE THE WIRE FROM THE GUIDE. VARIOUS INSTRUMENTS, INCLUDING A MALLET, WERE USED TO ASSIST IN EXTRACTION BEFORE PROCEEDING WITH THE CASE. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE EFFECTS RELATED TO THE ISSUE HAVE BEEN REPORTED FOR THE PATIENT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS- 06839528 THAT AN 0322-000 PARALLEL PIN GUIDE, BULLET NOSE, 3.2MM (PART OF THE 9913-000 7.0MM CANNULATED SCREW SYSTEM CASE) MALFUNCTIONED DURING A CASE. THE K-WIRE GUIDE WITHIN THE 7.0 CANNULATED SCREW SET APPEARED TO GET COLD WELDED WITH A K-WIRE. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072158 PARALLEL PIN GUIDE, BULLET NOSE, 3.2MM SCREW, FIXATION, BONE HWC ARTHREX, INC. PARALLEL PIN GUIDE, BULLET NOSE, 3.2MM 240504 00888867521698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown