Model Number N/A |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).G2: foreign: japan.Visual evaluation of the returned product found the sterile barrier (blister) exhibits damage visually consistent with thermal damage.Sterility has been breached.This complaint has been confirmed by review of the returned product.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.The condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the packaging operator not following the work instructions provided.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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It was reported that the shape of the plastic inner tray was deformed.It looked as if it had been melted by heat.This implant was used however the inner tray can be returned.There was no known impact or consequences to the patient.Attempts have been made and no further information has been provided.
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Event Description
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No further information 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.The following sections were {update/corrected} updated: g3; h2; h3; h10.Visual evaluation of the returned product found the sterile barrier (blister) exhibits damage visually consistent with thermal damage.Review of the internal evaluation and tensile test results by the manufacturing site found the blister deformity does not affect the sterility.Review of complaint history found no additional related issues for the reported product.The condition of the device when it left zimmer biomet is considered non-conforming to specification.The root cause of the reported event is the packaging operator not following the work instructions provided.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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