BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - SCREWS: RECON

    MDR report key: 12001232 · Received June 15, 2021

    Report

    Report Number
    8030965-2021-04952
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 15, 2021
    Report Date
    May 21, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREWS: RECON/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 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. 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 THAT ON (B)(6) 2021 DURING AN EXPERT LATERAL FEMORAL NAIL (LFN) PROCEDURE, TWO (2) UNKNOWN LFN NAILS WERE INCOMPATIBLE WITH THE LOCKING IMPLANTS AND INSTRUMENTS. THE UNKNOWN AIMING ARM, GUIDEWIRE, RECON SCREW, SLEEVE, AND INSERTION INSTRUMENT WERE MISALIGNED WITH THE HOLES IN THE LFN NAIL. WHEN THE GUIDEWIRE AND AIMING ARM WERE REMOVED, THE DEVICES WERE ABLE TO LINE UP. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE OUTCOME OF THE PROCEDURE IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS: RECON (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). UNKNOWN DRILL BIT (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) UNK - SCREWS: RECON. THIS IS REPORT 3 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901522 UNK - SCREWS: RECON SCREW,FIXATION,BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1