The returned device was shipped to the supplier, (b)(4), for evaluation.The supplier confirmed the event.The sample was inspected for the reported event and it was observed that the crossbars had broken and separated away from the reamer shell.Upon magnification, the reamer teeth were inspected and most of them were observed to be dull and worn.Worn reamers will exhibit decreased cutting efficiency over time and will require additional forces to ream correctly causing additional stress on the welded edges of the cross bars.These additional forces can cause the observed breakage.The failure mode is attributed to wear.Dull reamers occur as a result of the product exceeding its expected use.Manual surgical instruments have a limited life span which is generally determined by wear or damage due to repeated intended use.Ifu instructs customers and end users to visually inspect instrument fir damage and wear and to discard instruments with dull cutting edges or damages.The lot number could not be confirmed.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.No further investigation is required.
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