Reported issue ¿ it was noticed that the carbon boot was cracking/splintering along a top lip during pre-surgery check.Case type: tka.Product identification ¿ the returned device was confirmed to be a mako boot assembly catalog# 210080, ln: 201743082802.Product inspection ¿ visual inspection confirmed the top of the boot has carbon splintering.See attached evidence.Product history review ¿ review of the device history records indicate (b)(4) device(s) were manufactured under catalog# 210080, ln: 201743082802 and all devices were accepted into final stock on 02 dec 2017.No non-conformance was found during the inspection.Review of the device history records indicate (b)(4) device(s) were manufactured under catalog# 210080, ln: 201743082802 and all devices were accepted into final stock on 01 aug 2017.No non-conformance was found during the inspection.Conclusion - the event was confirmed.Preventive maintenance is where an action occurs that identifies device deterioration which may compromise function.Under pm conditions no patient was involved, and no actual or potential patient harm existed for the alleged event.No additional investigation or specific actions are required.
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