Investigation results: visual investigation: investigation was carried out visually.We detected a broken nose of the locking hook.This could be caused by a lack of lubrication on the sliding surface of the ratchet.Due to this lack of lubrication, friction was caused and finally this led to the breakage.The device requires regular lubrication as it involves metal on metal friction.Additives to machine cleaning processes by our experience have only limited lubrication effects, so we recommend the regular usage of special instrument oils to avoid such issues.Therefore, it is necessary to follow the point from the ifu ta011172 2021-09 change no.64.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.
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