BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI SPIRAL BLADE 60MM FOR TI RETROGRADE FEMORAL NAILS-EX

    MDR report key: 11925024 · Received June 2, 2021

    Report

    Report Number
    8030965-2021-04497
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Report Date
    May 6, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819829282
    PMA / PMN Number
    K033618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DEVICE PRODUCT CODE: HWC. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE LOANER KIT INSPECTION IT WAS OBSERVED THAT TI SPIRAL BLADE 60MM FOR TI RETROGRADE FEMORAL NAILS-EX IS STUCK IN EXTRACTION SCREW. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) TI SPIRAL BLADE 60MM FOR TI RETROGRADE FEMORAL NAILS-EX. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818688 TI SPIRAL BLADE 60MM FOR TI RETROGRADE FEMORAL NAILS-EX ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 07611819829282

    Patients

    Seq Age Sex Outcome Treatment
    1 EXTRACTION SCREW