Model Number 912082 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/27/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4) g2: foreign: japan multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2023 -01221 product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
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Event Description
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It was reported that the clear sleeve on the instrument did not slide.Another product was used to complete the procedure.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.
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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 one inserter was returned without sutures and the anchor, but the second one does have the sutures and anchor with the anchor not installed on the tip.Both inserter tips are bent and the sleeve positions are consistent with a device that has been used.Both inserters were function checked according to the attached memo and function as intended.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.For the sliding sleeve issue: the reported event is not confirmed.For the bent tip issue: the reported event is confirmed as the needle tips returned bent.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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