BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 15265062 · Received August 22, 2022

    Report

    Report Number
    3025141-2022-00258
    Event Type
    Malfunction
    Date Received
    August 22, 2022
    Report Date
    August 18, 2022
    Manufacturer
    ACUMED, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION WERE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS DEVICE INFORMATION (MODEL NUMBER AND BATCH/LOT NUMBER) IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS AN ISSUE WITH THE PART NUMBER 80-1625 POLARUS 3 NAIL TARGETING LOCKING BOLT (BATCH # 398349). IT WAS REPORTED THE TARGETING LOCKING BOLT "CAUSED THE NAIL TO 'SLIP' MEANING THAT THEY COULD NOT LINE UP THE NAIL WITH THE JIG TO PLACE THE SCREWS". DEVICE INFORMATION FOR THE NAIL INVOLVED IN THIS EVENT IS UNKNOWN. ATTEMPTS TO OBTAIN FURTHER INFORMATION REGARDING THIS EVENT AND THE PATIENT WERE MADE TO NO AVAIL. THIS REPORT IS RELATED TO REPORT NUMBER 3025141-2022-00257 FOR THE TARGETING LOCKING BOLT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2487500 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ACUMED, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown