BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC CRANIOTOME, BM

    MDR report key: 3970295 · Received December 11, 2013

    Report

    Report Number
    1045834-2013-15965
    Event Type
    Malfunction
    Date Received
    December 11, 2013
    Report Date
    October 11, 2011
    Manufacturer
    DEPUY SYNTHESES POWER TOOLS
    Product Code
    GFF
    PMA / PMN Number
    K974025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND THE REPORTED PROBLEM WAS CONFIRMED; THE DISTAL BEARING WAS DAMAGED AND THE INNER RACE OUT OF ALIGNMENT, CREATING AN OBSTRUCTION THAT WOULD NOT ALLOW CUTTER INSERTION. THE REMAINING BEARINGS WERE OBSERVED TO BE DRY OF LUBRICANT. THIS CONDITION MAY BE DUE TO NORMAL WEAR OUT FROM USE OVER TIME, BUT WAS LIKELY EXACERBATED BY EXCESSIVE SIDE LOADING DURING USE AND IMPROPER OR INEFFECTIVE CLEANING AND MAINTENANCE OF THE DEVICE. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE (B)(6) STATING THAT THE DEVICE HAD A "DOES NOT FUNCTION" ISSUE. THE DEVICE WAS USED DURING A SURGICAL PROCEDURE. NO USER OR PT INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648857 PEDIATRIC CRANIOTOME, BM GFF DEPUY SYNTHESES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1