Patient weight is unknown.(b)(4).The device broke intra-operatively and was not fully implanted or explanted.Per facility, the complainant parts have been discarded and are no longer available for evaluation.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that a patient underwent a surgical procedure on (b)(6) 2016 to repair two (2) bones in the right hand.During final tightening, the heads of two (2) screws spun off leaving the shafts in the third or fourth metacarpal bones.The heads were retrieved and discarded.Efforts were then made to extract the shaft fragments from the bone with the use of hemostat and a screw removal tray.Ultimately, the surgeon decided to leave the fragments in situ in order to avoid creating a big hole in the patient's finger.Per the surgeon, no additional cuts were made during the screw removal attempt.The issue resulted in a forty (40) minute surgical delay, but it is unclear as to whether or not additional anesthesia was administered during this time.The patient's post-operative status was reported as stable.This report is 1 of 2 for (b)(4).
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