MAKO SURGICAL CORP. FEMORAL TRIAL SLAPHAMMER; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
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Catalog Number 111140 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/04/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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Slap hammer screw broke off into the uni femur trial.
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Event Description
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Slap hammer screw broke off into the uni femur trial.
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Manufacturer Narrative
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An event regarding crack/fracture involving a mako slaphammer was reported.The event was confirmed after examination of the returned device.Method & results: product evaluation and results: the slaphammer tip fracture is consistent with an overload fracture as indicated by the ductile, mixed-mode, and intergranular fracture morphologies.The slaphammer met the drawing requirement for hardness.The intergranular fracture morphology is potentially due to hydrogen embrittlement.Eds showed the slaphammer was consistent with a 465 ph stainless steel alloy.Medical records received and evaluation: not performed as no medical information was received for review product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been 6 other similar events for the lot referenced.Conclusions: the investigation concluded that the slaphammer tip fracture is consistent with an overload fracture as indicated by the ductile, mixed-mode, and intergranular fracture morphologies.The slaphammer met the drawing requirement for hardness.The intergranular fracture morphology is potentially due to hydrogen embrittlement.Eds showed the slaphammer was consistent with a 465 ph stainless steel alloy.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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