Model Number N/A |
Device Problem
Failure to Cut (2587)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.E1 telephone number: (b)(6).G2 country: netherlands.
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Event Description
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It was reported that outside of surgery the device does not cut properly.There was no patient involvement.Due diligence is in process and there is no additional information available.There was no adverse event associated with the malfunction.
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the position of the control bar was not correct and the unit was out of calibration at 0 reading.The shaft bearings and sleeve bearings were replaced and the control bar was recalibrated and resolved the reported issue.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No additional information is available regarding the event.
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Search Alerts/Recalls
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