(b)(4).Exact date of post-operative blade migration and onset of pain is unknown.(b)(4).Although a revision procedure was performed on (b)(6) 2016, the nail was not explanted.The complainant part is not expected to be returned for manufacturer review/investigation.Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: manufacturing location: (b)(4) - manufacturing date: may 14, 2015 - expiration date: april 30, 2025.No non-conformance reports were generated during production.A 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.The sterility documentation was reviewed and determined to be conforming.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 hardware removal procedure on (b)(6) 2016 due to helical blade migration.The patient was originally treated on (b)(6) 2016 during which time a trochanteric fixation nail (tfn) and blade were inserted.It was noted that a screw was not used during this initial procedure.On an unknown post-operative date, the patient suffered a fall and began experiencing pain.X-ray images taken thereafter confirmed that the helical blade had cut out of the nail and migrated into the pelvis.The patient was returned to the operating room where only the blade was removed.Although the surgeon noted that the locking mechanism of the nail appeared to be in the incorrect position, a decision was made to leave the nail in situ.The procedure was completed with no reports of surgical delay or additional intervention.Post-operatively, the patient was noted to be stable.This report is 2 of 2 for (b)(4).
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