BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR OSCILLATOR

    MDR report key: 9465177 · Received December 13, 2019

    Report

    Report Number
    8030965-2019-71029
    Event Type
    Malfunction
    Date Received
    December 13, 2019
    Date of Event
    January 1, 2019
    Report Date
    November 29, 2019
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    HWE
    UDI-DI
    07611819110793
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. CONCOMITANT MEDICAL PRODUCTS: THE DATE RETURNED TO MANUFACTURER WAS INCORRECTLY DOCUMENTED AS UNKNOWN ON THE INITIAL REPORT. THIS DATE HAS BEEN UPDATED TO NOVEMBER 22, 2019. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    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. CORRECTION: D10: THE DATE RETURNED TO MANUFACTURER WAS DOCUMENTED AS NOVEMBER 22, 3019 ON THE PREVIOUS SUPPLEMENTAL MEDWATCH REPORT. THIS DATE HAS BEEN UPDATED TO NOVEMBER 26, 2019. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY. DEVICE EVALUATION: THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. DURING REPAIR, IT WAS DETERMINED THAT THE DEVICE HAD INSUFFICIENT/LOW POWER. IT WAS NOTED THAT THE AIR OSCILLATOR DEVICE HAD LOW POWER AND THUS OSCILLATIONS WERE BELOW SPECIFIED LIMITS. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK OSCILLATION FREQUENCY. THEREFORE, THE REPORTED CONDITION THAT THE DEVICE ROTATIONS WERE BELOW THE RECOMMENDED MINIMUM LIMIT WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE OF THIS CONDITION WAS DETERMINED TO BE TRACED TO COMPONENT FAILURE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS RETURNED FOR SERVICE; HOWEVER, DID NOT MEET MANUFACTURING SPECIFICATIONS DURING PRE-REPAIR ASSESSMENT. HOWEVER, SINCE THE INVESTIGATION IS STILL ON-GOING, THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. ONCE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND REPAIR, IT WAS DETERMINED THAT THE AIR OSCILLATOR DEVICE ROTATIONS WERE BELOW THE RECOMMENDED MINIMUM LIMIT. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK POWER WITH TEST BENCH. 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
    1263367 AIR OSCILLATOR INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES PRODUCTS LLC 07611819110793

    Patients

    Seq Age Sex Outcome Treatment
    1