BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 7365279 · Received March 23, 2018

    Report

    Report Number
    8030965-2018-52337
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Report Date
    February 28, 2018
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE MANUFACTURING SITE NAME WAS DOCUMENTED AS DEPUY SYNTHES PRODUCTS LLC (OBERDORF) IN THE INITIAL REPORT. THIS HAS BEEN UPDATED TO SYNTHES PRODUKTIONS GMBH (WALDENBURG). PLEASE NOTE THAT THE CONTACT OFFICE NAME/ADDRESS HAVE BEEN UPDATED ACCORDINGLY TO REFLECT THE CORRECTED MANUFACTURING FACILITY. THE SERIAL NUMBER AND DATE OF MANUFACTURE WERE DOCUMENTED AS UNKNOWN IN THE INITIAL REPORT. THE SERIAL NUMBER AND DATE OF MANUFACTURE HAVE ALL BEEN UPDATED ACCORDINGLY. THE UDI HAS ALSO BEEN UPDATED ACCORDINGLY. DEVICE EVALUATION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND DETERMINED THAT THE DEVICE WAS FUNCTIONAL AND PASSED THE PRE-REPAIR DIAGNOSTIC ASSESSMENT. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED AND AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. HOWEVER, DURING EVALUATION, IT WAS DETERMINED THAT THERE SIGNS OF UNKNOWN LIQUID ON TOP OF THE MOTOR AND THE BEARINGS AND GEAR SLEEVE WERE CORRODED. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD SIGNS OF AN UNKNOWN LIQUID ON TOP OF DUE TO IMPROPER CLEANING. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(6). THE SERIAL/LOT NUMBER WAS UNKNOWN; THEREFORE, THE DATE OF MANUFACTURE WAS UNKNOWN. (B)(4). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT THE SMALL BATTERY DRIVE DEVICE AUTOMATICALLY TURNED ON WHEN THE DRILL WAS NOT ON SAFETY. 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 THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THIS EVENT WAS UNKNOWN. 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
    210149 SMALL BATTERY DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES PRODUCTS LLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1