Model Number N/A |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).Combination product ¿ yes.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
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Event Description
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It was reported the inner sterile packaging was damaged.The dust bag of bone cement was not completely sealed.The outer box was completely closed.A delay of 15 minutes was reported.No further information has been made available.
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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.Evaluation of returned device found the left supplier sealing was opened on all the length.The manufacturer sealing was intact.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to supplier packaging issue.Corrective action has been initiated to address reported issue.If any further information is found which would change or alter any conclusions or information, a supplemental will be filled accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It was reported that the inner sterile packaging leaked.There was no patient involvement.
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Search Alerts/Recalls
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