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Catalog Number 912082 |
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 07/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03172, 0001825034-2020-03174, 0001825034-2020-03175, 0001825034-2020-03176.Concomitant medical devices: part# 912082; lot# 003010; part# 912082; lot# 504430; part# 912082; lot# 554580; part# 912082; lot# 725310.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 four (4) weeks ago during surgery, the clear sleeve of the juggerknot mini would not move.The surgeon tried using five (5) different juggerknot minis of the same model, all which had this problem.There was a surgical delay for an unknown amount of time.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.Visual examination of the returned product identified 5 juggerknot minis were returned because the clear sleeve wouldn¿t move smoothly.3 returned with sutures and anchors and 2 did not.4 of 5 have the sleeve fully deployed against the handle upon receipt.Item and lot numbers are not confirmed as they are not etched on the part.All 5 devices were function checked according to the functional testing of the juggerknot mini sleeve memo.All 5 function as intended and are 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 products were 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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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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