Model Number N/A |
Device Problems
Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.
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Event Description
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It was reported the locking ring was loose and was unable to lock the debridement tip.There was also leaking and no power to the device during surgery.The tip was detached but did not fall into the patient.There was no harm,no injury and no delay involved.There was no adverse event reported as a result of this malfunction.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Visual examination of the returned product identified that the face gear and plunger were missing from the assembly.There were no signs of physical damage to the device.Functional testing determined that the device would power on but that there was no suction and the motor created a high pitched noise.No issues were able to be duplicated with the tip lock.Device is used for treatment.The root cause of the reported issue is attributed to manufacturing.The event is confirmed.
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Event Description
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There is no additional information.
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Search Alerts/Recalls
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