Catalog Number 912082 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was discarded by hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Zimmer biomet will continue to monitor for trends.Associated products and reports 0001825034-2023-00497.Item#912082; lot#0002466225.
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Event Description
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It was reported during surgery the clear sleeve on the device would not slide as intended, causing a minor delay in surgery while the surgeon prepared another device.No pieces were retained by the patient.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Associated products and reports: 0001825034-2023-00497-1.Item#912082; lot#0002466225.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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