One (b)(4) disposable acromionizer 4.0 ep 1 blade reported on.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.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will be revisited.Factors that may affect device performance include: device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity that are unrelated to manufacture include: 1) blade hand piece not fully loaded and or locked into mdu hand set.2) incompatible force or torque or leverage applied.3) change of approach during use.4) insufficient irrigation or engaging the device without suction.5) seizing of blades due to inadequate bio matter excision.Final product met predetermined specs upon release to distribution.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ¿patient information ¿surgical procedure/post-operative care review ¿device labeling (including technique guides, ifus, etc.) no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.
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