Model Number N/A |
Device Problems
Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: item# 912082; lot# 827960; jgrknt 1.0mm mini 3-0 ndls; item# 912082; lot# 474830; jgrknt 1.0mm mini 3-0 ndls.Foreign: event occurred in (b)(6).The product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00094, 0001825034-2021-00095.Discarded.
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Event Description
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It was reported that the surgeon couldn't insert the anchor since the sleeve didn't work properly.Attempts have been made and additional information on the reported event is unavailable.No adverse events have been reported as a result of the malfunction.
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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.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmerbiomet will continue to monitor for trends.
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Search Alerts/Recalls
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