BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHYSICA - PATELLAR PEGS DRILL

    MDR report key: 11602676 · Received April 1, 2021

    Report

    Report Number
    3008021110-2021-00023
    Event Type
    Malfunction
    Date Received
    April 1, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 1, 2021
    Manufacturer
    LIMACORPORATE
    Product Code
    JWH
    PMA / PMN Number
    K151266
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BY CHECKING THE DHR OF THE LOT #1802874, NO PRE-EXISTING ANOMALIES WERE DETECTED ON THE PIECES MANUFACTURED WITH THIS LOT #. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THIS LOT #. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Description of Event or Problem · 1

    DURING KNEE SURGERY PERFORMED ON (B)(6). 2021, THE PHYSICA - PATELLAR PEGS DRILL (PRODUCT CODE 9065.95.120, LOT# 1802874) BROKE. ACCORDING TO THE INFORMATION REPORTED BY THE COMPLAINT SOURCE, NO EXCESSIVE FORCE WAS APPLIED AS THE SURGEON WAS DRILLING THE PATELLA. EVENT HAPPENED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501338 PHYSICA - PATELLAR PEGS DRILL PATELLA DRILL JWH LIMACORPORATE 9065.95.120 1802874

    Patients

    Seq Age Sex Outcome Treatment
    1 Other