BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - NAILS

    MDR report key: 9369413 · Received November 25, 2019

    Report

    Report Number
    8030965-2019-70551
    Event Type
    Injury
    Date Received
    November 25, 2019
    Date of Event
    October 26, 2019
    Report Date
    November 5, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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

    CONCOMITANT DEVICE REPORTED: HYBRID INSERTION HANDLE (PART# 03.037.011, LOT# 9881139, QUANTITY# 1) UNKNOWN HAMMER/MALLET (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY#1).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN NAIL. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. INITIAL REPORTER IS A SYNTHES EMPLOYEE. 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. (B)(4). 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A HIP FRACTURE WITH TUMOR REMOVAL SURGERY ON (B)(6) 2019, THE SURGEON PLACED A NAIL DIAMETER 11 (IT WAS INDICATED TO BE 10), INTRODUCED THE NAIL, AND WHEN HE DECIDED TO REMOVE IT, IT COULD NO LONGER BE DONE; IN THIS PROCESS OF ATTEMPTING THE WITHDRAWAL, THE IMPACTOR BROKE, LEAVING IN THE INSERTION ARCH A FRAGMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY, NO FRAGMENT WAS LEFT IN PATIENT. THERE WAS A DELAY OF 10-15 MINUTES. HE WAS ABLE TO REMOVE THE TUMOR LOCATED IN THE UPPER AREA OF THE NECK OF THE FEMUR, THE SURGEON MENTIONS THAT HE DOES NOT NEED TO BLOCK THE NAIL WITH THE DISTAL SCREW. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTION HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN HAMMER/MALLET (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY#1). THIS IS 2 OF 2 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164652 UNK - NAILS ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention