Catalog Number 00771100440 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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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).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the ml taper stem was protruding out of plastic sterile tray inside of the box.The outside box itself was not damaged.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.The following sections were updated/corrected updated: d4 expiration date and udi number; g3; h2; h3; h6 visual examination of the returned product found the stem has punctured through the sterile pouch and sterile inner blister.Sterility has been breached.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded the most likely root cause of the event can be attributed to transit damage.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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