Model Number 212480 |
Device Problems
Detachment of Device or Device Component (2907); Premature Separation (4045)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/04/2019 |
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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Over the last two weeks three mics powers have needed replacement due to screws in the mouth, where the attachments insert, breaking or falling out.Attachments are very loud during cutting and vibrating violently.Attachments seem to be running mics.All attachments need replacement.Case type: tka.
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Event Description
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Over the last two weeks three mics powers have needed replacement due to screws in the mouth, where the attachments insert, breaking or falling out.Attachments are very loud during cutting and vibrating violently.Attachments seem to be running mics.All attachments need replacement.Case type: tka.
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Manufacturer Narrative
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Reported event: it was reported that over the last two weeks three mics powers have needed replacement due to screws in the mouth, where the attachments insert, breaking or falling out.Attachments are very loud during cutting and vibrating violently.Attachments seem to be running mics.All attachments need replacement.Case type: tka product evaluation and results: the product was not evaluated as the product was unavailable for inspection capa (b)(4) has been raised for the same.Device history review a review of the device history records indicate 50 devices were manufactured and all were accepted into final stock on 01/16/18 with no reported discrepancies.Complaint history review a review of complaints in catsweb and trackwise related to p/n 212186, lot number 35011217 shows 2 additional complaints related to the failure in this investigation.The complaints are pr 2239935 , 2254646.Conclusion the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.
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Search Alerts/Recalls
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