Model Number N/A |
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 12/09/2020 |
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 - 2021 - 00018.Concomitant medical devices: medical product: zimmer biomet juggerknot mini item #: 912082 lot #: 538020.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 that during procedure that occurred approximately one (1) month ago that product could not be inserted due to product sleeve being hard and could not insert anchor.Doctor attempted to use a second product and the same issue occurred.The surgery was successfully completed with a third device.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 the sleeves on both parts were hard to move.One had a bent nitinol shaft.One was returned with the anchor and one was not as seen.Both mini¿s were function checked and function as intended.Item and lot numbers were not confirmed as they were not etched on the parts.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Upon conclusion of the investigation, no problem was found with the given devices for the functioning sleeve issue.A definitive root cause cannot be determined for the bent tip issue.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 is available at the time of this report.
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Search Alerts/Recalls
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