BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIER TIBIAL PUNCH TOWER MOD

    MDR report key: 6321610 · Received February 10, 2017

    Report

    Report Number
    0001825034-2017-00583
    Event Type
    Malfunction
    Date Received
    February 10, 2017
    Date of Event
    August 15, 2016
    Report Date
    February 9, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWP
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PRO CODE- HWP. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. PRODUCT LIKELY LEFT ZIMMER BIOMET CONFORMING. VISUAL INSPECTION OF THE PRODUCT DETERMINED THAT THE TOWER BODY STEM WAS FRACTURED. THE STEM APPEARS TO HAVE EXPERIENCED EXCESSIVE FORCE HOWEVER, A ROOT COULD NOT BE DETERMINED. THIS DEVICE IS USED FOR TREATMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIBIAL PUNCH TOWER FRACTURED DURING USE. THE PATIENT DID NOT RETAIN A FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105443 PREMIER TIBIAL PUNCH TOWER MOD ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HWP BIOMET ORTHOPEDICS N/A 122780

    Patients

    Seq Age Sex Outcome Treatment
    1