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 Problems
Detachment Of Device Component (1104); Mechanical Problem (1384); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
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Event Date 01/03/2017 |
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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Right knee replacement.When the surgeon finished making his cut, he went to remove the cutting block and one of the pegs came off.It was left in patient but was later extracted causing a 5 minute delay.
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Manufacturer Narrative
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An event regarding pin disassociation 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 no other similar events for this 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.As a result, nonconformance (b)(4) was previously raised on 01-apr-2013.The supplier investigation, scope and corrective actions are detailed within the nc and corresponding capa (b)(4).Capa (b)(4) was effectively closed in april 2014.
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Event Description
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Right knee replacement.When the surgeon finished making his cut, he went to remove the cutting block and one of the pegs came off.It was left in patient but was later extracted causing a 5 minute delay.
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