Catalog Number 110024773 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 the adhesive seal was broken so the 'void' was showing.The account put this to the side and did not implant.Attempts have been made and additional information on the reported event is unavailable at this time.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned; visual and dimensional evaluations could not be performed.Review of the provided photo found the tamper seal and shrink have been removed.Residual adhesive from the tamper seal is present.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The condition of the device when it left zimmer biomet is conforming to specification as review of the photo and manufacturing records confirm the tamper seal was applied during the manufacturing process.The root cause of the reported event is likely related to re-distribution of the product, however, a definitive root cause cannot be identified, as we cannot confirm when or how the tamper seal was removed.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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Search Alerts/Recalls
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