Concomitant medical products: 1883672hs: bur; 1883672hs 3pk hi speed diamond 70deg, lot 0210983179 manufactured: 03/16/2016 use before: 03/14/2024.Product evaluation: 1883670hs: upon analysis, when compared to the assembly drawing: visually, the spiral wrap broke which would have resulted in the reported event.The section measured 1.9 from the tip to the break point.When viewed under magnification, there was gouging of the outside diameter of the inner shaft just proximal to the tip with corresponding damage to the outer tube support area (including a thinning of the wall).The inner shaft was gouged 0.67 from the distal face of the inner hub.The spiral wrap was twisted in on itself in a clockwise direction at the break point.The location of the break indicates a torsional load between the gouged area of the inner shaft and the spiral wrap proximal to the break.The information most likely indicates torsional load from use, combined with excess pressure, caused friction, which resulted in the gouging and subsequent break.The instructions for use warn that excessive pressure applied to a bur/blade may cause a fracture.Note: [excess: exceeded sufficient pressure required for operation].1883672hs: upon analysis, when compared to the assembly drawing: visually, the spiral wrap broke which would have resulted in the reported event.The section measured 1.7 from the tip to the break point.When viewed under magnification, there was gouging of the outside diameter of the inner shaft just proximal to the tip with corresponding damage to the outer tube support area (including a thinning of the wall).The spiral wrap was twisted in on itself in a clockwise direction at the break point.The location of the break indicates a torsional load between the gouged area of the inner shaft and the spiral wrap proximal to the break.The information most likely indicates torsional load from use, combined with excess pressure, caused friction, which resulted in the gouging and subsequent break.There was no evidence of improper manufacturing and therefore has been ruled out as a likely cause.The instructions for use warn that excessive pressure applied to a bur/blade may cause a fracture.Note: [excess: exceeded sufficient pressure requi red for operation].A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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