Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received and evaluated by npd and supplier quality.Visual observation under a magnification revealed, scratches in inside of outer blade, where inner base lines up.Chipping of metal on blades.Additionally chip on outer edge of outer assembly.Chipping and scratching of metal on same area of the blades.Preliminary discussions suggested that this was the result of the device hitting another hard object.A white paper was performed previously on this failure; the result indicated that the amount of shedding for this product is acceptable.The dhr review indicated that this batch of devices was processed with 1 incident not related to the complaint condition therefore, there is no evidence of manufacturing anomalies on the records reviewed.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).
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