Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign: canada.The 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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Event Description
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It was reported that upon opening the instruments, the scrubbed nurse realized that the depth gauge was missing its tip.The tip was not found on table nor on in the sterile sheets.The piece cannot be in patient since patient was not yet opened.There was no consequences or impact to the patient.It was reported that no further information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the provided pictures identified the tip of the gauge is fractured.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental 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 at the time of this report.
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Search Alerts/Recalls
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