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Model Number N/A |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/31/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see all associated reports: 0001825034-2018-08697, 0001825034-2018-08698, 0001825034-2018-08699.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.
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Event Description
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It was reported that while restoring implant tubs in the distributorship, unsterile trauma nails were discovered.The inner sterile packaging was opened inside the wrapped outer box.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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The product was evaluated through manufacturing review, however, the malfunction could not be confirmed for this device.The device was returned to zimmer biomet, however, the device was dispositioned due to an open sterile package recall and was unable to be physically evaluated.The device history records were reviewed and no discrepancies were identified.The root cause is determined to be inadequate work procedures/instructions and distribution not being integrated into the company's quality management system.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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