MAKO SURGICAL CORP. FEMORAL TRIAL SLAPHAMMER; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Catalog Number 111140 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/12/2018 |
Event Type
malfunction
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.
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Event Description
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The screw part of the slap hammer was broken before the case started.Case type: pka.
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Manufacturer Narrative
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An event regarding crack/fracture involving a mako slaphammer was reported.Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was reported that the screw part of the slap hammer was broken.Material analysis of the returned device noted that the slaphammer tip had fractured.Mixed-mode and intergranular fracture morphologies were observed on the slaphammer, consistent with an overload condition.The slaphammer met the drawing requirement for hardness.The intergranular fracture morphologies are potentially due to hydrogen embrittlement.Eds showed the slaphammer was consistent with 465 ph stainless steel alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The device was discovered during inspection.There was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance; 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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The screw part of the slap hammer was broken before the case started.Case type: pka.
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