Model Number N/A |
Device Problems
Battery Problem (2885); Expulsion (2933); Explosion (4006)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).(b)(6).Once the investigation is complete, a follow up/final report will be submitted.
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Event Description
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It was reported that during the surgery, it was found that the batteries were exploded inside of the sterile tray before opened this complaint product.There was no harm or injury to the patient.There was a delay of 0-15 minutes to prepare an alternate product to complete the procedure.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 available.
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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 and provided pictures identified that the battery pack was busted open and debris and internal parts of the battery pack were found throughout the package.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Device is used for treatment.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.The event is confirmed.
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Search Alerts/Recalls
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