BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - NAIL HEAD ELEMENTS: FRN RECON SCREW

    MDR report key: 12980687 · Received December 10, 2021

    Report

    Report Number
    8030965-2021-10136
    Event Type
    Malfunction
    Date Received
    December 10, 2021
    Date of Event
    November 14, 2021
    Report Date
    November 13, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). ADDITIONAL NARRATIVE: 510K: THIS REPORT IS FOR AN UNK - NAIL HEAD ELEMENTS: FRN RECON SCREW/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. REPORTER IS A J&J REPRESENTATIVE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, IT WAS IT WAS NOTICED THAT WIRES AND DRILL BIT WERE MISSING THE NAIL WHEN INSERTED THROUGH THE AIMING ARM OF THE FRN. FRN NAIL WAS REMOVED AND PFNA NAIL INSERTED. THE SURGERY WAS COMPLETED WITH UNKNOWN TIME DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - INSERTION INSTRUMENT (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1) UNK - SCREWS: RECON (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1) UNK - GUIDES/SLEEVES/AIMING: AIMING ARM (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1) THIS COMPLAINT INVOLVES THREE(3) DEVICES. THIS REPORT IS FOR (1) UNK - NAIL HEAD ELEMENTS: FRN RECON SCREW THIS IS REPORT 4 OF 5 OR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1878112 UNK - NAIL HEAD ELEMENTS: FRN RECON SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK - GUIDE/COMPRESSION/K-WIRES| UNK - GUIDES/SLVS/AMING: AMING ARM| UNK - INSERTION INSTRUMENTS: TRAUMA| UNK - SCREWS: RECON