One 72200730 dyonics 4.0mm acromioblaster burr product reported on.The complaint states: ¿it was reported that it takes a lot of effort for the bone cutter to take some of the bone.The bone cutter blade produced small chips of metal in the joint.They were removed by flushing out.A backup device was available to complete the procedure with no significant delay or patient injuries.¿ the product was not returned for evaluation.Due to product unavailability, the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation were not fully possible without evaluation of physical product.Factors that may affect device performance include: device ability, surgical ability, implant location and tissue condition.Shedding material condition has been found to be consistent with the device having inadvertent pressure applied while deburring which causes wear bands on the inner blade surface.The symptom points to excessive lateral load during use causing a mis-alignment of the inner and outer blade resulting in the shedding.Excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly.Final product met predetermined specifications upon release to distribution.No patient harm or injury is being reported as a result of this device related incident, and all of the metal debris was flushed out.There is no indication of adverse patient consequence as a result.No further clinical assessment is warranted based on the information provided.
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