BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER FOR GRAFT SHAPING

    MDR report key: 6982720 · Received October 27, 2017

    Report

    Report Number
    3008021110-2017-00100
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    PHX
    PMA / PMN Number
    K161120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ANOMALIES DETECTED BY CHECKING THE DHR OF THE LOT# INVOLVED ON A TOTAL OF (B)(4) PIECES MANUFACTURED WITH THE SAME LOT #(2016AG0D8). NO OTHER COMPLAINTS REPORTED ON THE SAME LOT#. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.

    Description of Event or Problem · 1

    INTRA-OPERATIVE BREAKAGE OF THE REAMER FOR GRAFT SHAPING (MODEL# 9013.75.474, LOT# 2016AG0D8) WHEN CUTTING GLENOID BONE GRAFT. ACCORDING TO THE INFO REPORTED, NO PROLONGED SURGERY TIME NOR CONSEQUENCES FOR THE PATIENT DUE TO THIS ISSUE. NUMBER OF USES OF THE INSTRUMENT UNKNOWN. EVENT HAPPENED IN (B)(6) ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762428 REAMER FOR GRAFT SHAPING REAMER FOR GRAFT SHAPING PHX LIMACORPORATE S.P.A. 9013.75.474 16AG0D8

    Patients

    Seq Age Sex Outcome Treatment
    1