Investigation results: visual investigation: at the tip of both instruments one of the two catches is missing.The broken off parts were not enclosed.We made a visual inspection of the instrument.Here we found that one of the two arms was found bent and stuck / jammed in the guiding slot.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.Explanation and rationale: without further knowledge about the circumstances we expect, that the surgeon spread the downtube not completely with the removal key as mentioned in the instructions for use (ifu), so that the catch bent during removal.Hints in the ifu for removing the downtube from the pedicle screw - loosen gold colored sleeve a on downtube 1-2 clockwise revolutions until the line marking is no longer visible note - if necessary, the locking wrench for downtube can be used to make loosening easier insert removal key from the top into the downtube up to the stop so that the line marking terminates flush with the head of the downtube twist removal key by 90 degrees to the downtube and remove from the site together with the downtube by pulling on the removal key repeat procedure for additional downtubes conclusion and measures / preventive measures: based upon the investigation results, the root cause is most probably usage-related.Based upon the investigations results a capa is not necessary.
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