Catalog Number SP-STA-1021 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products:: st trac tf 24mm burr hole pltcat# sp-sta-1021 lot# 730290.St trac tf 24mm burr hole pltcat# sp-sta-1021 lot# 730290.Report source: foreign country: (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.Multiple mdr reports were filed for this event, please see associated reports: 001032347 - 2021 - 00464, 001032347 - 2021 - 00465.
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Event Description
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It was reported there was foreign material found within sterile packaging during incoming inspection.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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This follow-up report is being submitted to relay additional information.Quantity of three st trac tf 24mm burr hole plt's were returned for evaluation.Visual examination determined the packaging to be sealed and labeled properly.No failures were found for the devices themselves.However, foreign material was noted within the sterile packages.The part and lot information was verified.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to manufacturing deficiency leading to foreign material in the sterile packaging.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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