BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR PEN DRIVE

    MDR report key: 8745734 · Received June 28, 2019

    Report

    Report Number
    8030965-2019-65863
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    January 1, 2019
    Report Date
    May 9, 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: 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. H4: THE DATE OF MANUFACTURE (DOM) WAS DOCUMENTED AS UNKNOWN IN THE INITIAL REPORT. THE DOM HAS BEEN CORRECTED TO OCTOBER 20, 2008. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE WAS UNAVAILABLE. THE MANUFACTURING LOCATION WAS UNKNOWN. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. DURING REPAIR, AN EVALUATION WAS PERFORMED AND IT WAS DETERMINED THAT THE DEVICE HAD INSUFFICIENT/LOW POWER. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION OF THE AIR PEN DRIVE DEVICE, IT WAS DETERMINED THAT THE DEVICE HAD INSUFFICIENT/LOW POWER. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK WITH TEST BENCH AND SPEED, CHECK EXTERNAL LEAK TIGHTNESS, CHECK INTERNAL LEAK TIGHTNESS, GENERAL CONDITION, AND CHECK HISTORY. IT WAS NOTED IN THE SERVICE ORDER THAT THE PERFORMANCE OF THE DEVICE WAS OUT OF SPECIFICATION. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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
    537393 AIR PEN DRIVE MOTOR, DRILL, PNEUMATIC HBB DEPUY SYNTHES PRODUCTS LLC 07611819830899

    Patients

    Seq Age Sex Outcome Treatment
    1