BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR PEN DRIVE

    MDR report key: 8982900 · Received September 10, 2019

    Report

    Report Number
    8030965-2019-68078
    Event Type
    Malfunction
    Date Received
    September 10, 2019
    Date of Event
    January 1, 2019
    Report Date
    August 28, 2019
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    HBB
    UDI-DI
    07611819830899
    PMA / PMN Number
    K093361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: 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. G1, H4: THE MANUFACTURING SITE NAME WAS DOCUMENTED AS UNKNOWN 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 DATE OF MANUFACTURE (DOM) WAS DOCUMENTED AS UNKNOWN IN THE INITIAL MEDWATCH REPORT. THE DOM HAS BEEN CORRECTED TO SEPTEMBER 17, 2007. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY. DEVICE EVALUATION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. DURING REPAIR, AN EVALUATION WAS PERFORMED AND IT WAS DETERMINED THAT THE AIR PEN DRIVE DEVICE HAD INSUFFICIENT/LOW POWER. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK INTERNAL LEAK TIGHTNESS, AND GENERAL CONDITION. THEREFORE, 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.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION WAS UNKNOWN. DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE WAS UNAVAILABLE. 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. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT THE AIR PEN DRIVE DEVICE HAD INSUFFICIENT/LOW POWER. 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 2019. 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
    776946 AIR PEN DRIVE MOTOR, DRILL, PNEUMATIC HBB DEPUY SYNTHES PRODUCTS LLC 07611819830899

    Patients

    Seq Age Sex Outcome Treatment
    1