STRYKER ORTHOPAEDICS-MAHWAH HEADED NAIL - 3/4"; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 6541-4-575 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Event Description
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There are 6541-4-575 3/4¿ headed nails in 6541-4-515 1 1/2¿ packaging.There were 2 delivered this way to (b)(6).Update: "they were delivered to the hospital new, unopened.A sterile processing employee opened one and realized it was the wrong pin (3/4¿ pin in a package labeled as 1 1/2¿ pin).They left the second package unopened.We are returning both.".
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Event Description
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There are 6541-4-575 3/4¿ headed nails in 6541-4-515 1 1/2¿ packaging.There were 2 delivered this way to community general.Update: "they were delivered to the hospital new, unopened.A sterile processing employee opened one and realized it was the wrong pin(3/4¿ pin in a package labeled as 1 1/2¿ pin).They left the second package unopened.We are returning both.".
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Manufacturer Narrative
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Triathlon headed nails (6541-4-5xx) are sold as non-sterile instruments in packages with an outer label that contains information for the product (nail) description, part number, and lot code.Once the nails are removed from their packaging, the packaging is discarded, and the nails are placed into an instrumentation tray and queued for sterilization.The triathlon headed nails must be sterilized prior to surgical use.The device was discovered prior to surgery during kit preparation with no patient involvement and no adverse consequences reported.A sofha (severity of harm assessment) was conducted and concluded the highest potential of harm would be an s1 for a knee surgery with tourniquet.Based upon this review, it is unlikely that a serious injury or death would result if this event were to recur.Therefore, this event was re assessed as not reportable.
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Search Alerts/Recalls
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