Model Number N/A |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.Unique identifier (udi)# : n/a.
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Event Description
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It was reported that a hair was found inside the sterile package.No adverse events to the patient.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned product identified hair-like debris within the sealed sterile pouch.Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the product when leaving zimmer biomet was not conforming to specifications.The root cause of the reported issue is attributed to operator error during the manufacturing process.Corrective action has been initiated.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.Unique identifier (udi) #: (b)(4).
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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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