BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0 CM SHORT ATTACHMENT

    MDR report key: 8261937 · Received January 18, 2019

    Report

    Report Number
    1045834-2019-52624
    Event Type
    Malfunction
    Date Received
    January 18, 2019
    Date of Event
    January 1, 2018
    Report Date
    January 4, 2019
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    HBC
    UDI-DI
    845384008798
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE REVIEW: A REVIEW OF THE SERVICE HISTORY RECORD INDICATES THAT THE DEVICE HAS NOT BEEN SERVICED FOR A SERVICE CONDITION THAT IS RELEVANT TO THE CURRENT REPORTED CONDITION. DEVICE EVALUATION: THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. DURING REPAIR, IT WAS DETERMINED THAT THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO WEAR FROM NORMAL USE OVER TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BEARINGS OF THE SHORT ATTACHMENT DEVICE WERE DAMAGED, THE NOSE CONE WAS DAMAGED, AND THE IDENTIFICATION WAS UNREADABLE. IT WAS FURTHER DETERMINED THAT THE TRIANGLE SYMBOL WAS MISSING, A PEN HP-0033-02 HAD WANDERED, THE EXTENSION SLEEVE WAS DAMAGED, AND THE BALL BEARINGS WERE WORN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VIBRATION, LOCK OPERATION, AND VISUAL ASSESSMENT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2018. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55163 5.0 CM SHORT ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES PRODUCTS LLC N/A 845384008798

    Patients

    Seq Age Sex Outcome Treatment
    1