BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE PIN

    MDR report key: 4927924 · Received July 17, 2015

    Report

    Report Number
    3006460162-2015-00006
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    August 15, 2015
    Report Date
    August 15, 2015
    Manufacturer
    ORTHOPEDIATRICS CORP.
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RISK OF POTENTIAL OR ACTUAL SERIOUS HARM IS NOT SIGNIFICANT. RATIONALE: TIP OF THREADED GUIDE WIRE LEFT IN PATIENT BONE AFTER SURGERY IS COMMON AND WELL REPORTED IN THE LITERATURE. THIS PIN WAS MADE TO ASTM STANDARD F562 "STANDARD SPECIFICATION FOR (B)(4) FOR SURGICAL IMPLANT APPLICATIONS. MATERIAL HAS BEEN ANALYZED AND DEEMED ACCEPTABLE FOR LONG TERM IMPLANTABLE EXPOSURE. NO UNTOWARD EFFECT ON PATIENT EXPECTED AND NO ADVERSE EVENT REPORTED BY SURGEON.

    Description of Event or Problem · 1

    GUIDE PIN (INSTRUMENT) BROKEN AT THE JUNCTION WHERE THE THREADS ON THE TIP MEET THE SHAFT. TIP OF GUIDE PIN REMAINS IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467174 GUIDE PIN PIN, MANUAL SURGICAL INSTRUMENT MDM ORTHOPEDIATRICS CORP. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN