This event was not initially reported as there was no clinical complications.This customer complaint was re-evaluated in (b)(6) 2018 to see if the event were to reoccur could a serious injury occur.Since a malfunction of this type may result in either complications or a prolonged procedure, a decision was made to file this as an mdr.Investigation conclusion: this item is a delicate product with a thin footplate which is specifically designed for small bones in the cervical area.One of the important aspects of using this product is not to twist or pry the instrument while cutting the bone.Moreover product cannot be used on larger bones.Product was used unintendedly or the product fell on the floor or on steel table and the thin foot place got all the force of impact in that small area and as a result it cracked.The product is very durable for normal intended use against any pressure, stress and is very hard and difficult to break.But it is vulnerable to shock though - impact against a hard object.(b)(4).
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