The mfr did not receive devices for review.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, and amended medical device report will be submitted.(b)(4).
|
Trend analysis: a trend was identified.A trend investigation has been initiated.Review of incoming information: laser marking is not readable on every device.No pictures were available.Devices analysis: all devices have a laser marking on the shaft.Item and lot number is marked on the shaft.On the top/head of the bit, the size and the system of the bit is marked.The surface of the device on the top/head is rough.Therefore, the laser marking was not ideally placed on the top/head.Possible causes for the reported event according to dfmea: laser marking not legible on the top/head of the device due to inadequate design for intended handling performance.Possible as the performed investigation showed that the surface of the device on the top/head was rough.Therefore, the laser marking was not ideally placed on the top/head.Based on the given information and the results of the investigation, we could identify a root cause for this issue.The surface of the device on the top/head is rough.Therefore, the laser marking was not ideally placed on the top/head.A capa was initiated to eliminate the root cause.Zimmer's reference number of this file is (b)(4).
|