BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE COLLECTOR

    MDR report key: 4934101 · Received July 22, 2015

    Report

    Report Number
    1045834-2015-11664
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Report Date
    June 23, 2015
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    KDC
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE PACKAGING OF ALL SEVEN BONE COLLECTORS WERE FOUND TO BE COMPLETELY CRASHED. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. IT WAS DETERMINED THAT THE PACKAGING WAS RAN OVER BY HEAVY CART WHEELS OR SQUEEZED BETWEEN TWO SURFACES AT THE CUSTOMER SITE AS ALL SEVEN BONE COLLECTORS INSIDE WERE CRASHED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO MISUSE / ABUSE AND POSSIBLY USER ERROR. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 7 FOR THE SAME EVENT. IT WAS REPORTED THAT THE PACKAGING OF THE SEVEN BONE COLLECTOR DEVICES WERE DAMAGED AND THE DEVICES INSIDE EACH PACKAGING WERE BROKEN. ACCORDING TO THE REPORT, THE SHIPPING BOX WAS UNDAMAGED. THE EVENT WAS NOT REPORTED TO HAVE OCCURRED DURING SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THERE WAS NO PATIENT INVOLVEMENT. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477611 BONE COLLECTOR BONE PARTICLE COLLECTOR - BONE COLLECTOR KDC DEPUY SYNTHES POWER TOOLS J133104571

    Patients

    Seq Age Sex Outcome Treatment
    1