Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Device history records review was conducted.The report indicates that the: manufacturing location: (b)(4), manufacturing date: 11.Feb.2014.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 during a hardware removal of a lateral entry femoral nail, the extraction device appeared be partially stripped and wouldn't thread into the nail.The initial surgery was performed a week ago.Post-operatively, after reviewing x-rays, the surgeon stated that the wrong implant was used and that he didn't like the way the nail was aligning, and therefore decided to perform a revision surgery to have a plate implanted instead.On (b)(6) 2016, patient was brought back and the femoral nail and screws were removed intact.There was no allegation of misalignment against the implants.Patient was revised with a smith and nephew plate.Another extraction screw from a different nail set was used to complete the surgery without any complications.Patient status was stable and there was no surgical delay.This complaint involve 1 part.Concomitant devices reported: unknown femoral nail (part# unknown, lot# unknown, quantity 1).This report is 1 of 1 for (b)(4).
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