Model Number N/A |
Device Problems
Loose or Intermittent Connection (1371); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/14/2023 |
Event Type
malfunction
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Event Description
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It was reported that during testing that the depth of cut lever was not working correctly; not graduating properly and sticky.There was no harm or injury as there was no patient involvement.Also, an alternate device was available for immediate use.Due diligence is complete and no additional information is available.No adverse event reported.
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Manufacturer Narrative
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This event is recorded by zimmer biomet under (b)(4).G2, country event occurred in: australia the product is in the process of being evaluated by zimmer biomet.Once the product investigation has been completed, a follow up/final report will be submitted.
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Manufacturer Narrative
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This event is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the thickness control lever was loose.The lever, ball plunger, semi-circle bearings, and vespel bearings were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.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 incident.
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Search Alerts/Recalls
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