(b)(4).No product at hand.Batch history review: because the batch number is unknown, a batch history review is not possible.Conclusion and root cause: the root cause for the problem is most probably usage related.Rationale: without further knowledge about the circumstances we assume, that the shaving was generated by screwing in the screw with a wrong angle, so that the thread scrapped the edge of the plate (screw hole).This is the basic cause in cases like that.A material defect or a manufacturing error can be excluded.
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It was reported metal shavings detaching from the screw intraoperatively.The reporter indicated the surgeon drilled and then screwed in and locked in the first two screws in c4, then drilled and screwed in the third screw in c3.This resulted in metal abrasion/ and a metal shaving sheared off from the screw (thread).The shaving was removed and the screw remained implanted.This also happened when screwing in the fourth screw.Again the shaving was removed and the screw was left implanted.Additional information has been requested, however, not yet received.Associated medwatch: 9610612-2019-00281 (fourth screw).
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