Catalog Number 209063 |
Device Problems
Difficult to Remove (1528); Non Reproducible Results (4029)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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¿as part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.¿.
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Event Description
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Saw attachment sticking in mics handpiece.Very large force required to remove.Once removed oil visible tka.
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Event Description
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Saw attachment sticking in mics handpiece.Very large force required to remove.Once removed oil visible tka.
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Manufacturer Narrative
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Reported event: it was reported that the saw attachment could not be detached from the mics.Product evaluation and results: the product was unavailable for inspection as the product was not returned.Product history review: device history records indicate (b)(4) devices were manufactured under lot k0anl and (b)(4) devices were accepted into final stock on 14 aug 2018.A review of qt17-12-0063 revealed that the issue is not related to the failure alleged in this compliant.Complaint history review: a review of complaints related to p/n 209063, s/n (b)(4) in prodex lot k0anl shows no additional complaints related to the failure in this investigation.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that nc (b)(4) and capa 1450904 are associated with the failure mode reported in this event.
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Search Alerts/Recalls
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