STRYKER ORTHOPAEDICS-MAHWAH ADJUSTMENT BLOCK - STANDARD; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 6541-1-600 |
Device Problems
Device Operates Differently Than Expected (2913); Material Deformation (2976); Scratched Material (3020)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/11/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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During a tka, after pinning the guide for distal femur cut as standard for an 8mm resection, the cut was "basically air balling" (rep defined: when the surgeon put the saw through the guide and capture, the saw was not hitting any bone, instead of resecting 8mm of bone off the distal femur).The case was completed successfully.
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Manufacturer Narrative
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An event regarding annoyance (airballing) involving a triathlon other instrument was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual inspection showed the device to have scratching associated with normal use.Some damage was noted on the locking shaft assembly, consistent with contact with additional instrumentation.Examination of returned device by a material analyst engineer indicated: "in-service use damage observed." medical records received and evaluation: there is no indication that patient factors contributed to the reported event.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.There have been no other event for the lot referenced.Conclusions: it was reported that during a tka, after pinning the guide for distal femur cut as standard for an 8mm resection, the cut was airballing.A visual inspection showed the device to have scratching associated with normal use.Some damage was noted on the locking shaft assembly.Examination of returned device by a material analyst engineer indicated: "in-service use damage observed." therefore the event of 'airballing' was not confirmed.No further investigation for this event is possible at this time.If additional information becomes available, this investigation will be reopened.
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Event Description
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During a tka, after pinning the guide for distal femur cut as standard for an 8mm resection, the cut was "basically air balling" (rep defined: when the surgeon put the saw through the guide and capture, the saw was not hitting any bone, instead of resecting 8mm of bone off the distal femur).The case was completed successfully.
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Search Alerts/Recalls
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