Model Number N/A |
Device Problems
Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/24/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).Reporter had indicated that product will be returned.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 that foreign substances were inside of the sterile packages.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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(b)(4).This report is being submitted to relay additional information.Reported event has been confirmed by review of actual devices received.Review of the device history records for item # 51-103100 and lot # 6241545 identified following deviations or anomalies: ncr 1803160847 was created for porous coat issue (no coating); all parts of the lot were reworked.Ncr 1804082219 was created for porous coat issue (failed gauge); all parts of the lot were reworked.Ncr 1804220844 was created for incorrect finish; 2 parts were scrapped.These ncrs are not related to the reported event.The likely condition of the products when leaving zimmer biomet were non-conforming.The reported event occurred during the manufacturing process.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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