Device Problem
Expulsion (2933)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/08/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The complaint is being reported by zimmer biomet as (b)(4).The product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the device worked "ok during the procedure and nobody was harmed.However, at the end of the case the nurse noticed blackening on the battery pack.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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This complaint is recorded with zimmer biomet under (b)(4).Review of the device history record could not be performed as no lot number was reported for this complaint.Product examination could not be performed as no product was returned for this complaint.Pictures provided by the customer show that the battery ruptured but the conditions of this rupture are undetermined.This complaint cannot be confirmed.The root cause of the reported event could not be specifically determined with the provided information.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
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Event Description
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Investigation results revealed that the battery ruptured.
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Search Alerts/Recalls
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