Catalog Number 180737-1 |
Device Problem
Device Difficult to Setup or Prepare (1487)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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As reported: "during the case there was an issue with the first 7x8mm tibial poly used as the poly would not lock into place properly.A second 7x8 poly was opened and locked into place using same technique with no issues on first try".Rep confirmed a surgical delay of 1 minute.
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Event Description
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As reported: "during the case there was an issue with the first 7x8mm tibial poly used as the poly would not lock into place properly.A second 7x8 poly was opened and locked into place using same technique with no issues on first try".Rep confirmed a surgical delay of 1 minute.
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Manufacturer Narrative
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An event regarding seating/locking issue involving a mako insert was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection of the returned device indicates there are a number of scratches on the surfaces of the device consistent with attempted implantation and explantation damage.Material analysis: damage observed on the insert consistent with attempted implantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: one insert was returned for evaluation.There are scratches on the surfaces of the insert consistent with attempted implantation and explantation damage.The event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as images of the device taken when the alleged event was identified is required to complete the investigation for confirming the event and determining a root cause.
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Search Alerts/Recalls
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