Model Number N/A |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Udi: (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.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 when the circulating nurse opened the package, there was a hole in the 3.5mm 33 headed screw wrapper and the screw was not between the plastic protection sleeve.
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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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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Visual evaluation of the provided picture identified an open tyvek lid with a small defect that may be a hole, which cannot be confirmed.There is indication that the product was being used as the package is opened.However, the screw and the plastic sleeve are not visible on the provided picture.Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the part when it left zimmer biomet control is considered conforming based on the dhr review but cannot be confirmed.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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