Catalog Number 6541-1-705E |
Device Problems
Break (1069); Device Dislodged or Dislocated (2923); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problems
No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
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Event Date 05/26/2016 |
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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The surgeon mr (b)(6), reported that a piece broke off the triathlon cutting block during surgery.The surgeon further reported that he impacted the device and when he took it off one of two metal 'spikes' had broken off the device and remained lodged in the patient's bone.The surgeon was able to remove the piece from the patient with no lasting effect.There was a 2-3 minute delay to surgery as a result of the reported event.The case was completed successfully.
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Manufacturer Narrative
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An event regarding pin dissociation of a triathlon 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 2 similar previous reported events.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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The surgeon mr (b)(6), reported that a piece broke off the triathlon cutting block during surgery.The surgeon further reported that he impacted the device and when he took it off one of two metal 'spikes' had broken off the device and remained lodged in the patient's bone.The surgeon was able to remove the piece from the patient with no lasting effect.There was a 2-3 minute delay to surgery as a result of the reported event.The case was completed successfully.
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Search Alerts/Recalls
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