|
Device Problem
Migration (4003)
|
Patient Problem
Physical Asymmetry (4573)
|
Event Type
Injury
|
Manufacturer Narrative
|
This report is for an unknown femoral nail/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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.
|
|
Event Description
|
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the open reduction internal fixation (orif) surgery for trochanteric fracture of right femur with no prolongation of the operation time.Preoperative ct scan showed an intramedullary fracture, and the surgeon only performed closed reduction on a traction table and did not perform extramedullary reduction in the surgery.X-ray taken 1 week after surgery showed that the bone head was dislocated posteriorly.The lm image of the postoperative x-ray showed that the fracture site was internally fixed in the intramedullary region.In the x-ray which was taken 1 week after surgery, it was found that the bone fragments were telescoped by each other about 1 cm with no bony support.And also, it was found that in the bone a nail has moved with a locking screw as a axis.Future actions regarding this event will be determined from now on.No further information is available.This report is for (1) unknown femoral nail.This is report 1 of 2 for complaint (b)(4).
|
|
Search Alerts/Recalls
|
|
|