During an open reduction internal fixation right distal radius and scaphoid fracture, the needle holder broke in the wound.All pieces were found and visualized.Two x-rays were taken, confirming that there was no foreign body in wound.No patient injury, death or surgical delay was reported.
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Despite several attempts to obtain the device or photographs of the device, the needle holder was not returned.Therefore, it was impossible to perform an evaluation of the device or to determine the batch code of the device, although the lot number reveals that it was manufactured either on august 1 or on september 7, 2017.No issues were found in the corresponding device history records, confirming that device conformed to specifications at time of release.
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