It was reported that the tibial left cutting block had a rough place from the saw blade on the medial side of block.This could rip gloves as it was passed.They returning, no one was injured, surgery was not delayed.They had 2 articular surface pieces that was broken, unfortunately this did happen in surgery, they were mistakenly disposed of during wash cycle, do not had these to return.Surface pieces racked in 2 pieces, this did not delay surgery, no one was injured and not returning these, as they never appeared after wash.They had pictures of each item.No surgical delay.
|
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
|