Catalog Number 6541-2-807 |
Device Problem
Sticking (1597)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/19/2015 |
Event Type
malfunction
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Event Description
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When opening trays for case, scrub tech noticed sticky film on the handle which came off on the tech's glove.Handle was removed from field and a new set was opened to perform the case (no patient in room at time of discovery).After case concluded, all other sets were opened and inspected and additional handles were identified with same issue of sticky film on handles and were removed from use accordingly.
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Manufacturer Narrative
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When completed, the investigation results will be submitted in a supplemental report.
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Manufacturer Narrative
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An event regarding a sticky handle involving a tibial alignment handle was reported.Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review indicates there has been one other event for the lot referenced.Conclusion: when opening the trays for a case, the scrub technician noticed a sticky film on the handle.The handle was removed from field and a new set was opened to perform the case (no patient in room at time of discovery).There was no surgical procedure associated with the reported event.After case concluded, all other sets were opened and inspected and additional handles were identified with same issue of sticky film on handles and were removed from use accordingly and returned to stryker for evaluation.A visual inspection of the returned device confirms the reported event.This event meets the definition of preventive maintenance; no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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When opening trays for case, scrub tech noticed sticky film on the handle which came off on the tech's glove.Handle was removed from field and a new set was opened to perform the case (no patient in room at time of discovery).After case concluded, all other sets were opened and inspected and additional handles were identified with same issue of sticky film on handles and were removed from use accordingly.
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Search Alerts/Recalls
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