BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTSCR F/AFN/UFN/CFN+SPIRAL BLADE

    MDR report key: 7822266 · Received August 28, 2018

    Report

    Report Number
    8030965-2018-56013
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Date of Event
    August 9, 2018
    Report Date
    August 9, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819281226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. LOT NUMBER IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, SURGERY TO REMOVE A DISTAL FEMORAL NAIL WAS PERFORMED. DURING THE SURGERY, A SCRUB NURSE PASSED THE INCORRECT EXTRACTION SCREW TO THE SURGEON BY MISTAKE. IT WAS DIFFICULT TO ATTACH THE EXTRACTION SCREW TO THE NAIL. HOWEVER, IT WAS ATTACHED TO THE NAIL, AND THE REMOVAL OPERATION WAS COMPLETED SUCCESSFULLY. THE SURGERY WAS COMPLETED WITH A 30-MINUTE DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE: DISTAL FEMORAL NAIL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR AN EXTRACTION SCREW FOR AFN/UFN/CFN + SPIRAL BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665372 EXTRACTSCR F/AFN/UFN/CFN+SPIRAL BLADE MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH 07611819281226

    Patients

    Seq Age Sex Outcome Treatment
    1