BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY HANDPIECE/MODULAR FOR TRS

    MDR report key: 7406598 · Received April 9, 2018

    Report

    Report Number
    8030965-2018-52851
    Event Type
    Malfunction
    Date Received
    April 9, 2018
    Date of Event
    March 10, 2018
    Report Date
    March 18, 2018
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    GEY
    UDI-DI
    7611819977815
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. CORRECTED DATA: THE MANUFACTURING SITE NAME WAS DOCUMENTED AS SYNTHES PRODUKTIONS GMBH (WALDENBURG) IN THE INITIAL REPORT. THIS HAS BEEN UPDATED TO OBERDORF SYNTHES PRODUKTIONS GMBH (OBERDORF). MANUFACTURE SITE NAME/ADDRESS HAS BEEN UPDATED ACCORDINGLY TO REFLECT THE CORRECTED MANUFACTURING FACILITY. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY. THE DEVICE MANUFACTURE DATE WAS DOCUMENTED AS MAY 7, 2013 IN THE INITIAL REPORT. THIS INFORMATION HAS BEEN UPDATED TO SEP. 19, 2014. THE UNIQUE IDENTIFIER( UDI) HAS BEEN UPDATED ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE 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 NOTED THAT THE DEVICE WAS CREATING A HEAVY NOISE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK OF FREE MOVING. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO IMPROPER HANDLING, 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. (B)(6). 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 (B)(6) THAT THE BATTERY HANDPIECE DEVICE WAS MAKING A HIGH SOUND WHILE IN USE WITH THE LID DEVICE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE 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
    251404 BATTERY HANDPIECE/MODULAR FOR TRS MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES PRODUCTS LLC 7611819977815

    Patients

    Seq Age Sex Outcome Treatment
    1