Catalog Number 5520-B-400 |
Device Problems
Delivered as Unsterile Product (1421); Device Damaged Prior to Use (2284); Device Packaging Compromised (2916); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/08/2015 |
Event Type
malfunction
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Manufacturer Narrative
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When completed, the evaluation summary will be submitted in a supplemental report.
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Event Description
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The surgeon reported to the sales representative that he takes the implants in himself and he noticed that when the first layer was pulled back, that the paper on the second layer was practically stripped back as if some adhesive was stuck on it.He presumed it would be ok to use but when he went to open the packaging directly underneath this area, the packaging was not sealed i.E.The adhesive was not there.The sales representative further reported that it had presumably been stuck on the outside of the packaging and then stuck to the inner part of the outer packaging.The surgeon felt it was safer not to use the device.The packaging has been untouched by anyone else.The case was completed using a different device.
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Manufacturer Narrative
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An event regarding a packaging issue involving a triathlon baseplate was reported.The event was confirmed.Method & results: device evaluation and results: the outer blister lid was wrinkled.In addition, the inner blister foam was stuck to the inner blister lid.It is noted that both blisters showed evidence of complete seal transfer.There is no indication that the sterility of the device was compromised.Medical records received and evaluation: not performed as the event is not related to patient factors.Device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the root cause was determined to be a known packaging issue.Packaging innovations is aware of this, and has issued a memo.
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Event Description
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The surgeon reported to the sales representative that he takes the implants in himself and he noticed that when the first layer was pulled back, that the paper on the second layer was practically stripped back as if some adhesive was stuck on it.He presumed it would be ok to use but when he went to open the packaging directly underneath this area, the packaging was not sealed i.E.The adhesive was not there.The sales representative further reported that it had presumably been stuck on the outside of the packaging and then stuck to the inner part of the outer packaging.The surgeon felt it was safer not to use the device.The packaging has been untouched by anyone else.The case was completed using a different device.
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Search Alerts/Recalls
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