Model Number N/A |
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 Date 09/26/2022 |
Event Type
malfunction
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Event Description
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It was reported that the sterile barrier of the implant container was punctured.A new device was used to complete the surgery.Event was found in the operating room however, there was no direct patient involvement.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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(b)(4).Product has been returned to zimmer biomet for the investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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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: updated: g3; h2; h3; h6.Product was returned and evaluated.A visual evaluation of the returned product found the label was cut, likely due to opening the carton.The stem had punctured thru all sterile barriers.The sterility had been breached.This complaint has been confirmed.Medical records were not provided.A review of the device history records identified no deviations or anomalies during manufacturing.The condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported 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 additional event information to report at this time.
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Search Alerts/Recalls
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