Additional information: d9 - product return.H3 - yes, evaluation.H6 - codes updated.Investigation results: aesculap ag carried out a visual and microscopic examination.A repair stamp was found, indicating that the instrument had been repaired in france by aesculap technical services (ats).The movable jaw was broken off - the fragment, which could provide further clues as to the reason for the deviation, is not available to us.The fracture surface shows a forced fracture due to overloading.The hardness was tested and found to be 471 hardness according to vickers (hv) 5, which is within the specification of 420 +110 hv5.Batch history review: the lot number was not provided.A review was not performed.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, additional medical intervention.Conclusion/preventive measures: based upon the investigation results, a definitive root cause cannot be determined.The results show no hints for a product or manufacturing error.Notes from the electronic instructions for use eifu) ta011658 2020-10 v6 change no.62252 on this: damage or destruction of the jaws due to overload! only use rongeurs as intended (i.E.Ablation of soft tissue).Do not cut or lever out bones or adjacent bone structures.Avoid overloading the jaws by tearing off or holding and levering tissue or by lateral loading through twisting, lateral strain due to twisting.Do not use rongeurs with blunt cutting edges, send them in for repair.Do not remove more fabric than will fit into the openings of the jaws.Based upon the investigation results, a capa is not required.
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