Catalog Number 912082 |
Device Problems
Positioning Failure (1158); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported that the surgeon couldn¿t insert the anchor as the sleeve was hard.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies were found.A definitive root cause cannot be determined.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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