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Misonix received complaint number (b)(4) on november 7, 2019 that the tip of mxa-d214 sonastar aspiration tip 1.6mm micro short, sterile, detached during a "hepatectomy" performed by dr.(b)(6) and was found on top of the patient's liver.A serious injury to the patient or user was not reported.Medical intervention required to preclude a serious injury was not reported.Delay in treatment was not reported.Dhr review: a review of the dhr for mxa-d214 sonastar aspiration tip 1.6mm micro short, sterile, which is a sterile kit containing multiple component parts could not be completed.The lot number for the mxa-d214 sonastar aspiration tip 1.6mm micro short, sterile was not reported by the hospital and the customer did not return any portion of the sterile mxa-d214 procedure pack.Customer stated the product was not saved for return.A review of incoming inspection records for the mxa-d214 sonastar aspiration tip 1.6mm micro short, sterile cannot be conducted because the lot number was not reported and a review of incoming inspection records individual components cannot be performed because the etched lot numbers were not reported.Misonix has shipped/sold 1098, mxa-d214 sonastar aspiration tip 1.6mm micro short, sterile between 11/01/2018 through 10/31/2019.Trend analysis: a review of the rma file indicates that two (2) mxa-d214 sonastar aspiration tip 1.6mm micro short, sterile , including this one, were returned to misonix from 11/08/2018 to 11/08/2019, where the customer stated problem was a damaged/broken tip.A defect rate of 0.18% is calculated on 1098, mxa-d214 sonastar aspiration tip 1.6mm micro short, sterile disposables sold/shipped from 11/01/2018 through 10/31/2019.The complaint defect rate is below the rate estimated in the original risk assessment; therefore, there is no change in risk probability, residual risk, or risk-benefit-ratio.Engineering evaluation: this complaint is associated with rma # (b)(4) which was not received from the user.An evaluation could not be performed.The predominant failure mode for ultrasonic disposables that break during use is a partial or complete fracture.They typically do not shatter or create multiple un-retrievable fragments that would be difficult to locate or remove.Because the surgical procedure is performed under visualization by a surgeon, in some case enhanced by loupe or a microscope, the instrument failure can be promptly identified.Furthermore, the system is design to emit alerts/ alarms when the tips fracture, further communicating to the user that something abnormal has occurred.When the tip fractures, triggering the alarm, the device stops energizing the handpiece to which the tip is attached.The broken pieces can be easily visually identified, in some cases aided by the use of enhanced visualization by routine loupe-fitted eyeglasses or microscopes and removed from the surgical field.Surgical suites typically have access to x-ray equipment and would be able to quickly identify and locate any fragments not found by direct or enhanced visualization by using such equipment.The fractured piece can therefore be found and extracted quickly and easily without significant delay in the surgical procedure.The tips are shipped as sterile components in multiple packages; therefore the tip can replaced with a new one without significant delay in the surgical procedure.In the event that the sonastar aspiration tip couldn't be used to complete the procedure surgical suites have access to alternative technologies that can be used to complete the surgical procedure without significant delay in treatment.Contact of the ultrasonic tip or the exposed extension with metal, surgical instruments or other objects during ultrasound must be avoided.Such contact can damage the ultrasonic components very easily and may result in compromised performance, including failure.Discard any extensions or tips that show signs of damages like gouges, nicks or fractures.The sonastar ifus contains the following warnings and cautions: warning 1.2 the sonastar system is intended to be used in various types of invasive, surgical procedures.There may be indirect danger to the patient should the device fail during the procedure.It is recommended that the facility follows its back-up equipment protocols.Caution 6.12 vibrating tip contact with hard objects can cause tip damage.Caution 7.1 be careful not to damage the tip when sliding the torque wrench over the tip.System failure may result from scratches or damage to the tip when vibration is active.Note 8.2 do not clean the tip with abrasive or metallic materials, as damage to the tip may result in device failure.A serious injury to the patient or user was not reported.Medical intervention required to preclude serious injury was not reported.Delay in treatment was not reported.Therefore, there are no safety and efficacy concerns to address.There are no adverse trends noted.The complaint defect rate is below the rate estimated in the original risk assessment; therefore, there is no change in risk probability, residual risk, or risk-benefit ratio.Conclusion: since, the device was not returned, a definitive root cause could not be determined.A potential root cause is that the device was used in a manner inconsistent with manufacturer recommendations.A serious injury to the patient or user was not reported.Medical intervention required to preclude a serious injury was not reported.Delay in treatment was not reported.This event is being reported to the us fda because the user stated an mdr report would be sent to the fda by the institution.
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