Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation.Reported event: it was reported that "during a mako tka the surgeon had difficult maintaining a registration on the tibia and femur.On inspection the array itself was wobbly at the centre attachment." the event was not confirmed.Method & results: -device evaluation and results: not performed as no items were returned.-product history review: review of the device history records indicates 100 device(s) were manufactured and accepted into final stock on 14may2018 with no reported discrepancies.-complaint history review: a review of complaints in catsweb and trackwise related to p/n 112280, lot 19160218 shows 00 additional complaint(s) related to the failure in this investigation.Conclusion: the exact cause of the event could not be determined because the product was not received.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.Product surveillance will continue to monitor for trends corrective action/preventive action: no action is required at this time as there is no confirmed failure mode.H3 other text : product was not available for evaluation.
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