MAKO SURGICAL CORP. TIBIAL INLAY IMPACTOR HEAD; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
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Catalog Number 160177 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not available.
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Event Description
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Plastic attachment of the inlay impactor broke apart during driving in.Inlay was already inserted.
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Manufacturer Narrative
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An event regarding crack/fracture involving a mako impactor tip was reported.The event was confirmed through device inspection.Method & results: device evaluation and results: examination of the returned device with engineer indicated that the device is fractured due to an overload condition as indicated by hackles observed on fracture surface.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the investigation concluded that the device fractured due to an overload condition as indicated by hackles observed on fracture surface.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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Plastic attachment of the inlay impactor broke apart during driving in.Inlay was already inserted.
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Search Alerts/Recalls
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