Catalog Number 112290 |
Device Problems
Output Problem (3005); Non Reproducible Results (4029)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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As part of the 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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During a mako tka the surgeon had difficult maintaining a registration on the tibia and femur.On inspection the array itself was wobbly at the centre attachment.Surgical delay of approximately 1 hour.
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Manufacturer Narrative
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Reported event: it was reported that "during a mako tka the surgeon had difficult maintaining a registration on the tibia and femur.On inspection the array itself was wobbly at the centre attachment." the event was not confirmed.Method & results: device evaluation and results: not performed as no items were returned.Product history review: review of the product history records indicate 100 devices were manufactured under lot no 19380118 and accepted into final stock on 03/07/2018.No non-conformance were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 112290, lot 19380118 shows 01 additional complaint(s) related to the failure in this investigation.These include the following pr(s):(b)(4).Conclusion: the exact cause of the event could not be determined because the product was not received.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no confirmed failure mode.H3 other text : product was not available for evaluation.
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Event Description
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During a mako tka the surgeon had difficult maintaining a registration on the tibia and femur.On inspection the array itself was wobbly at the centre attachment.Surgical delay of approximately 1 hour.
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Search Alerts/Recalls
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