Model Number 209063 |
Device Problems
Mechanical Problem (1384); Separation Failure (2547)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/03/2019 |
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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While making cuts during a tka procedure, the mics handle became loose and started to shake.Making it difficult for the surgeon to perform the cuts.Case type: tka.
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Event Description
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While making cuts during a tka procedure, the mics handle became loose and started to shake.Making it difficult for the surgeon to perform the cuts.Case type: tka.
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Manufacturer Narrative
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Reported event: while making cuts during a tka procedure, the mics handle became loose and started to shake.Making it difficult for the surgeon to perform the cuts.Case type: tka.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection.Product history review: review of the device history records indicate (b)(4) devices were manufactured under l/n: 42060818 , s/n: (b)(6) and (b)(4) devices were accepted into final stock on 07 sept 2018.A review of qt18-09-0023 209063 revealed that the issue is not related to the failure alleged in this complaint.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209063, lot number 42060818 shows 05 additional complaints related to the failure in this investigation.The complaints are (b)(4).Conclusion: the alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that (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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