Model Number N/A |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/12/2023 |
Event Type
malfunction
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Event Description
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It was discovered that during kit inspection it was difficult to connect the 3m hose and the unit.There was no patient involvment.Due diligence is complete.No further information is available.
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Manufacturer Narrative
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This event is recorded with zimmer biomet under (b)(4) this medwatch is being filed as an initial report.Customer has indicated that 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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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 the device did not work; failed spring seal and needle bearing.The spring seal and needle bearing were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.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 further information is available at this time.
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Search Alerts/Recalls
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