Catalog Number 00771100520 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/24/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This report will be amended when our investigation is complete.
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Event Description
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It was reported that the implant was presented to the sterile field and subsequently opened.The surgical technologist and sales representative immediately noticed a dark strand, about 1/2 inch long resembling a hair.There was no delay in surgery and surgery was completed with another device.
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Manufacturer Narrative
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This report will be amended when our investigation is complete.Received, and being evaluated.
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Manufacturer Narrative
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An m\l taper femoral stem was returned along with the outer packing for review.Visual inspection of the returned device confirms the presence of a hair like dark strand approximately ½ inch in length taped to the top of the foam insert.Follow up with the sales rep revealed that the foreign material was found on the foam insert itself.Follow up with the sales rep also confirmed that everyone in the sterile field were wearing surgical hoods and the hair like strand was observed when the package was opened.The inner packaging was not returned.It was noted that the outer packaging has minor damages likely from opening the packaging and shipping it back.Review of the device history records did not find any deviations or anomalies.This device is used for treatment.Product history search revealed no additional complaints against the related part and lot combination.Since the hair was found on the package after opening, the root cause cannot be definitively determined.
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Search Alerts/Recalls
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