BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM CANNULATED SCREW SHORT THREAD/36MM

    MDR report key: 3181689 · Received June 14, 2013

    Report

    Report Number
    3008500488-2013-00002
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 14, 2013
    Manufacturer
    EMERGE MEDICAL
    Product Code
    HWC
    PMA / PMN Number
    K102343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INCLUDED A THOROUGH REVIEW OF: MFG RECORDS AND CERTIFICATIONS, PRODUCT IFU, PREVIOUS CUSTOMER COMPLAINTS, FDA MDRS, AND CUSTOMER REPORT. THERE IS NO EVIDENCE OF LABELING OR IFU ANOMALIES. THE INVESTIGATION DID NOT REVEAL ANY EVIDENCE OF DESIGN, MFG OF LABELING ANOMALIES. NO CONCLUSION AS TO THE CAUSE OF THE BREAK COULD BE DRAWN SINCE THE PRODUCT WAS RETURNED DEFORMED AND DAMAGED. THIS INCIDENT IS THE FIRST THREAD BREAK PROBLEM REPORTED FOR CATALOG # 207.636.EM OR FOR ANY EMERGE CANNULATED SCREW IN THE HISTORY OF THE COMPANY, AND APPEARS TO BE AN ISOLATED INCIDENT. THE INVESTIGATION IS CLOSED AS INDETERMINATE BASED ON THE CONDITION THE COMPLAINT PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    DOCTOR INITIALLY THOUGHT THE HEAD BROKE OFF THE SCREW. HOWEVER, UPON FURTHER INSPECTION, IT APPEARED THE THREADING CAME OFF, SO DR (B)(6) MADE ANOTHER INCISION AND TOOK THE WHOLE SCREW OUT. DR NOTICED A SLIGHT KINK IN THE GUIDE WIRE. DR WAS ABLE TO RETRIEVE THE SCREW WITH THE THREADS AND HAD NO FURTHER COMPLICATIONS. NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271365 4.0MM CANNULATED SCREW SHORT THREAD/36MM BONE SCREW HWC EMERGE MEDICAL NA 130775

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention GUIDE WIRE