BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY HANDPIECE/MODULAR FOR TRS

    MDR report key: 7082752 · Received December 5, 2017

    Report

    Report Number
    8030965-2017-50296
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    October 31, 2017
    Report Date
    November 9, 2017
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    GEY
    UDI-DI
    07611819977815
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING SITE NAME WAS DOCUMENTED AS SYNTHES PRODUKTIONS GMBH (B)(4) IN THE INITIAL REPORT. THIS HAS BEEN UPDATED TO (B)(4) SYNTHES PRODUKTIONS GMBH. PLEASE NOTE THAT THE CONTACT OFFICE NAME/ADDRESS HAVE BEEN UPDATED ACCORDINGLY TO REFLECT THE CORRECTED MANUFACTURING FACILITY. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. DEVICE EVALUATION: THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. THE DEVICE WAS EVALUATED AND IT WAS DETERMINED THAT THE BEARING OF THE HANDPIECE DEVICE WAS NOT FUNCTIONING AND WAS DEFECTIVE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK OF FREE MOVING, AND CHECK THE ATTACHMENT COUPLING. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMPROPER MAINTENANCE, WHICH IS USER ERROR/MISUSE/ABUSE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REPORTER'S FULL NAME, EMAIL ADDRESS AND PHONE NUMBER WERE NOT PROVIDED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE HANDPIECE DEVICE WAS POWERLESS AND MAKING A STRANGE NOISE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. 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
    861116 BATTERY HANDPIECE/MODULAR FOR TRS MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES PRODUCTS LLC N/A 07611819977815

    Patients

    Seq Age Sex Outcome Treatment
    1