MAKO SURGICAL CORP. FEMORAL TRIAL SLAPHAMMER; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POL
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Catalog Number 111140 |
Device Problems
Break (1069); Detachment Of Device Component (1104); Sticking (1597)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 05/23/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Event Description
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During impaction of the size 5 lm femur trial, the slap hammer threads broke off into the trial.The slap hammer is broken, as well as the femur trial (tip of slap hammer stuck inside where it normally threads on to).
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Manufacturer Narrative
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An event regarding "fractured tip" involving a femoral trial slaphammer was reported.The event was confirmed.Device evaluation and results: examination of the returned device indicated the fracture surface was consistent with previously completed material analyses for the same product and issue.Material analysis was performed and concluded that "the slaphammer tip fractured in overload.Intergranular fracture morphologies were observed on the slaphammer.The slaphammer met the drawing requirement for hardness.Eds showed the slaphammer was consistent with 465 ph stainless steel alloy.It is recommended look into the heat treatment and hardness requirement for the 465 ph ss slaphammer." medical records received and evaluation: not performed as medical records were not provided for review.Device history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation concluded that based on the material analysis that "the slaphammer tip fractured in overload.Intergranular fracture morphologies were observed on the slaphammer.
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Event Description
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During impaction of the size 5 lm femur trial, the slap hammer threads broke off into the trial.The slap hammer is broken, as well as the femur trial (tip of slap hammer stuck inside where it normally threads on to.
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Search Alerts/Recalls
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