Model Number N/A |
Device Problem
Intermittent Loss of Power (4016)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under cmp-(b)(4).Once an evaluation of this device is completed, a follow-up/final report will be submitted.Telephone number: (b)(6).
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Event Description
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It was reported that the handpiece loses power during operation.No further information provided.No adverse events were reported as a result of this malfunction.
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Event Description
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No additional event information.
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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.Review of the most recent repair record determined the motor was losing speed.The motor was replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event is confirmed.
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Search Alerts/Recalls
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