MAKO SURGICAL CORP. TIBIAL INLAY IMPACTOR HEAD; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Catalog Number 160177 |
Device Problems
Crack (1135); Material Deformation (2976); Scratched Material (3020)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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As reported: "the plastic blue piece that goes on the tibial c impactor is cracked and falls off during the case".
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Manufacturer Narrative
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An event regarding crack/fracture involving an mako impactor was reported.The event was confirmed through product return.The blue foot attachment for the tibial impactor was returned for evaluation.The device was returned in a used condition.Scratches and dent marks are observed on the surface of the device.Examination of the returned device with engineer indicated that the device is worn due to in service use consistent with contact against hard object.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No medical records were received for review with a clinical consultant all devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.The blue foot attachment for the tibial impactor was returned for evaluation.The device was returned in a used condition.Scratches and dent marks are observed on the surface of the device.Examination of the returned device with engineer indicated that the device is worn due to in service use consistent with contact against hard object.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.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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As reported: "the plastic blue piece that goes on the tibial c impactor is cracked and falls off during the case".
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Search Alerts/Recalls
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