(b)(4).The returned device was confirmed to have loss of function and exhibit wear and tear from indicated use.The device functioned as intended by holding sufficiently the 2.4mm wire, but did not pass with the 3mm wire.The device was measured against the print specifications at several dimensions and it was confirmed that all measurements taken were within specification.The device history records were reviewed and the records indicated that the device met specifications at the time of manufacture.This device is used for treatment.The package insert included with the instrument specifies that the device may not perform as intended if damaged or worn.The most likely cause of the instrument not gripping the 3mm wire is wear and tear from use.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.
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