Model Number N/A |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Calibration Problem (2890)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.Telephone number: (b)(6).Device has not been received.
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Event Description
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It was reported that the device is taking deeper grafts than it should.There was a delay of 1-15mins.There was no harm to the patient.Thicker graft was taken.No additional graft was harvested.No adverse events were 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).Review of the most recent repair record determined that the unit's control bar was out of calibration.The control bar was recalibrated and resolved the reported issue.Device is used for treatment.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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Event Description
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No additional event information.
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Search Alerts/Recalls
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