Event year reported as 2018; however, exact date of postoperative helical blade cutout and neck fracture is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was 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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Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date, the patient complained of a restricted range of motion of the hip joint.The facility noted a trochanteric femoral nail advance (tfna) helical blade cut¿out when the patient consulted a surgeon and neck fracture was also confirmed.The patient had an osteosynthesis surgery with a trochanteric femoral nail advance (tfna) on (b)(6) 2018.Just after the surgery, the condition of the affected site was intramedullary type (p type).After the initial surgery, the patient was admitted to an emergency room due to a cranial nerve damage.The surgeon heard that the patient had fallen repeatedly after the surgery and wondered why the femoral neck fracture occurred though the tfna blade had been inserted.Furthermore, the surgeon commented that it was understandable if fracture occurred in other area such as the end of the tfna femoral nail.Reoperation to explant the tfna implants was performed on (b)(6) 2018.The procedure was successfully complete without surgical delay.Patient outcome was unknown and currently, the patient is no longer in the facility.This report captures the post-operative event of helical blade cutout and neck fracture, while related complaint (b)(4) captures the intra-operative issues that occurred during implant removal procedure.Concomitant devices reported: tfna femoral nail (part #: 04.037.042s, lot #: h501921, quantity: 1).Unknown locking screw (part #: unknown, lot #: unknown, quantity unknown).This report is for one (1) tfna helical blade 85mm sterile.This is report 1 of 1 for complaint (b)(4).
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