Catalog Number 180705-1 |
Device Problems
Break (1069); Material Deformation (2976); Material Integrity Problem (2978)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/25/2015 |
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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Mako 5x8mm insert was damaged while surgeon was trying to seat it on mako baseplate.Component was kept by rep, and case was unaffected and successful.Another 5x8mm tibial insert was used.No unusual circumstances experienced.
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Manufacturer Narrative
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An event regarding alleged damaged insert during a procedure was reported.The event was confirmed.Device review of the reported lot determined that the device was manufactured on 31-mar-2015.There have been no other events for the lot referenced.Visual inspection of the returned device confirmed that the device is damaged on the inferior and superior side due to attempt at implantation.Machine markings are still present.There are no signs of delamination or discoloration.Conclusion: the investigation confirmed that the device was damaged during attempt at implantation.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.
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Event Description
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Mako 5x8mm insert was damaged while surgeon was trying to seat it on mako baseplate.Component was kept by rep, and case was unaffected and successful.Another 5x8mm tibial insert was used.No unusual circumstances experienced.
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Search Alerts/Recalls
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