STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5520-B-600 |
Device Problems
Material Discolored (1170); 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 08/13/2015 |
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 scrub nurse and surgeon were concerned that when the triathlon device was being opened during the case, the packaging was allegedly slightly wrinkled and discolored.The customer further reported that the device had not been handed on to the table at the time so they were able to open another device and proceed as normal.
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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 released a memo regarding lidstock/foam sticking complaints dated 25-sep-2009 stating: stryker orthopaedics currently utilizes a void-filling approach to sterile product packaging.Product is placed in the package and supported with foams of various sizes, and these configurations are then validated.The foam serves to protect both the product and the package, preventing the product from moving within the package and damaging the sterile barrier.As the purpose of the foam is to tightly constrain the product, these package configurations are designed to reduce open space.As a result of this critical design function, sporadic issues of foam sticking to the package tyvek lidstock have been reported.Due to the infrequent nature of these complaints and the greater risk that would be presented by an undersized foam, these complaints will not be addressed through a design change.
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Event Description
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The scrub nurse and surgeon were concerned that when the triathlon device was being opened during the case, the packaging was allegedly slightly wrinkled and discolored.The customer further reported that the device had not been handed on to the table at the time so they were able to open another device and proceed as normal.
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Search Alerts/Recalls
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