Upon receipt at the hospital, the mako representative noted that the pn 180408 (patellofemoral component, size 8) implant from the pn 150135 (serial # (b)(4)) implant shipping container appeared to have an unidentified stain present under the shrink wrap on the box label.This implant was separated and placed in a (b)(4) bag for return.Two implants from the kit, which exhibited no visible damage, were used in the case.The remaining implants were returned ((b)(4)) to mako for evaluation.
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As part of normal complaint follow-up, an evaluation of the event was completed at mako surgical.A non-conforming report (npr) was created.The packaging configuration of the product referenced in (b)(4) consists of two redundant sterile barriers ((b)(4)), encased by a rigid plastic box.All product returned was visually inspected by a team of engineers.The inspection consisted of visually inspecting each layer of packing for discoloration.The engineer leading the inspection noted that none of the product returned had discoloration past the outer ridged plastic box.Mako has also followed up with the surgeon who implanted the device from the same kit of (b)(4) devices.The surgeon reported that the patient had no infection or post-operative complications.The (b)(4) returned units have been scrapped.
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