Catalog Number 6541-1-707E |
Device Problem
Break (1069)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 04/07/2015 |
Event Type
malfunction
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Event Description
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The customer reported that during a triathlon primary knee operation, the femoral cutting block was removed and the attachment pin had allegedly broken off the cutting block and was left embedded in the bone.The pin was noticed and removed.A replacement device was not needed because the femoral cuts had already been made.
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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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Manufacturer Narrative
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An event regarding pin dissociation from a triathlon cutting guide was reported.The event was confirmed.Method & 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 reported events for the reported lot id.Conclusions: the investigation concluded that the fixation peg disassociating from the triathlon 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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The customer reported that during a triathlon primary knee operation, the femoral cutting block was removed and the attachment pin had allegedly broken off the cutting block and was left embedded in the bone.The pin was noticed and removed.A replacement device was not needed because the femoral cuts had already been made.
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Search Alerts/Recalls
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