(b)(4).Manufacturing site evaluation: the instruments were not available for investigation.Batch history review - the product does not require batch management; a review of the device quality and manufacturing history records is not possible.Conclusion and root cause - no product available and therefore it is hardly possible to determine an exact conclusion and root cause.We assume that the cause of the failure is not product related.There is the possibility that the root cause of the problem is most probably usage related.Rationale - according to the quality standard a material defect and production error can be excluded.Without the product we cannot determine the exact cause.There is the possibility for a usage error due to improper handling or mechanical overload situation by torsion or high leverage with the instrument.According to the intended use: indication- the aesculap ronguers are used to remove soft tissue (e.G.Intervertebral disc tissue, mucous membrane, ethmoidal cells, cell tissue, nucleus tissue, sequester) in neuro and spinal surgery.Contraindication- the dismountable aesculap rongeurs are not suitable for removing bone or adjacent bone structures! for this purpose, we recommend the use of bone punches that can withstand higher mechanical loads.Due to the provided information."the customer scraped the disc".There is the possibility that the instrument was not used for its intended purpose.There is also the possibility that during scraping the movable open jaw may have been broken by lateral forces due to an overload.Possibly the instruments have been used to lever or scrape bones or adjacent bone structures.If further investigations are required, the product should be provided for examination.Furthermore, according to the instructions for use (ifu) the following points and caution must be observed: caution - damage or destruction of the jaws due to overload!.
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