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 01/20/2023 |
Event Type
malfunction
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Event Description
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It was reported that during surgery, the clear sleeve of the device would not slide as expected.Subsequently, another device was used to successfully complete the surgery.There are no reported consequences for this event.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).Event occurred in japan.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the returned product/provided pictures identified the tip of the device is bent.The part has been function tested and is conforming.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.
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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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