BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0 CM SHORT ATTACHMENT

    MDR report key: 8241950 · Received January 11, 2019

    Report

    Report Number
    1045834-2019-52603
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    January 1, 2018
    Report Date
    December 23, 2018
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    HBC
    UDI-DI
    845384008798
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. 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

    THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. DURING REPAIR, IT WAS DETERMINED THAT THE BEARINGS OF THE DEVICE WERE DAMAGED, THE NOSE CONE WAS DAMAGED, THE IDENTIFICATION WAS UNREADABLE, AND THERE WAS A COSMETIC DEFECT. IT WAS NOTED THAT THE BALL BEARING WAS DISASSEMBLED, MISSING BALLS AND THE CAGE WAS NOT AVAILABLE, THE EXTENSION SLEEVE WAS DAMAGED, A PIN HP-0033-02 HAS WANDERED, AND THE TRIANGLE SYMBOL WAS MISSING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LOCK OPERATION (RATTLE), TEMPERATURE, CUTTER INSERTION (BALL-BEARING), AND VISUAL ASSESSMENT (PIN). THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO NON-CONFORMANCES WERE DETECTED RELATED TO THE REPORTED CONDITION. 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 THE ATTACHMENT DEVICE HAD BECOME UNUSUALLY WARM. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO A PLANNED PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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
    31639 5.0 CM SHORT ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES PRODUCTS LLC N/A 845384008798

    Patients

    Seq Age Sex Outcome Treatment
    1