The product analysis indicates two opened samples of part number 1883670hs from lot number 0209944308 were received for evaluation.The returned samples were the same part / lot number and packaged together.It could not be determined which sample went with which regulatory report.The samples were analyzed together, and the results duplicated on each supplemental mdr.A microscope and calipers were used to evaluate the burs.Sample 1: the spiral wrap was stretched by ¼¿ which caused the inner assembly to protrude out of the outer tube support area.Sample 2: there was a fibrous green mat attached to the tip of the bur, however this is not likely to have contributed to the complaint.The locking area was deformed in such a way that indicates excess torsional load which may or may not have contributed to the complaint.Both samples: showed no signs of a break (raw materials separated), no detachment of components, and no heat discoloration.The distal end of the outer tubes was worn and gouged which is an indication of aggressive use such as prying or pushing to remove material during dissection.There was no allegation of a defect prior to use.The information most likely indicates axial bending / prying load from use, combined with excess pressure caused friction which resulted in the wear and gouging.Bur 1 of 3, regulatory report #: 1045254-2017-00493 bur 2 of 3, regulatory report #: 1045254-2017-00494 bur 3 of 3 was not returned for evaluation, regulatory report #: 1045254-2017-00495 if information is provided in the future, a supplemental report will be issued.
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