Model Number NB045Z |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/31/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
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Event Description
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It was reported that there was an issue with a enduro tibia hemi-wedge.According to the complaint description one of the tibia wedges was already open when customer wanted to use it.There was no case delay or impact to the patient.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).
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Manufacturer Narrative
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In the light of the small amount of information received and due to the circumstance that we did not receive the complained device/packaging for investigation, it is not possible to determine a root cause for the mentioned failure.According the 8d report no capa is necessary.
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Search Alerts/Recalls
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