Catalog Number 912076 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: foreign - event occurred in (b)(6).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.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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It was reported approximately one (1) month ago during surgery, the clear sleeve of the product did not move smoothly.The surgeon used another one to complete the surgery.Attempts have been made and no further information has been provided.
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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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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 device was returned because the sleeve would not move smoothly.The device was function checked according to the functional testing of the juggerknot mini sleeve memo and is conforming.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.No device problem found; the returned product was conforming during functional check.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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Search Alerts/Recalls
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