STRYKER ORTHOPAEDICS-MAHWAH SIZE #5 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR.; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 6541-1-705E |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 12/11/2015 |
Event Type
malfunction
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Manufacturer Narrative
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When completed, the investigation results will be submitted in a supplemental report.
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Event Description
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It was reported that during a primary surgery, surgeon removed the #5 cutting block and the fixation peg from the block remained in patient's bone.Surgeon removed the peg immediately and there was no delay or adverse consequence to patient or user and surgery completed accordingly.
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Manufacturer Narrative
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An event regarding pin dissociation of a size #5 4-in-1-cutting block captured assy.Tria.Exp.Inst.Was reported.The event was confirmed.Method and results: device evaluation and results: inspection of the returned device confirmed the pin had dissociated from the device body.Additional dimensional inspection was not performed as it was confirmed the product was within scope of the associated capa.Medical records received and evaluation: not performed as there was no indication that patient factors contributed to the reported event.Device history review: all devices accepted into final stock conformed to specification.This review confirmed the device was manufactured prior to capa implementation.Complaint history review: there have been no similar previous reported events for this lot id.Conclusions: the investigation concluded that the fixation peg disassociating from the triathlon 4:1 express cutting block was caused by a manufacturing nonconformance.It was concluded that the supplier, (b)(4), had not performed the required press fit operation between the peg and block which led to the pin coming out of the assembly.Stryker reserves the right to re-evaluate this investigation if additional relevant information becomes available.
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Event Description
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It was reported that during a primary surgery, surgeon removed the #5 cutting block and the fixation peg from the block remained in patient's bone.Surgeon removed the peg immediately and there was no delay or adverse consequence to patient or user and surgery completed accordingly.
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