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Product complaint # (b)(4).
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.
Reporter is a j&j sales representative.
A review of the device history record has been completed.
The investigation could not be completed; no conclusion could be drawn, as no product was received.
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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It was reported that on (b)(6) 2019, the patient underwent surgery for trochanteric fracture of femur with tfna.
After surgery, on unknown date, the patient fell.
In early (b)(6) 2022, when the patient visited the hospital because of pain due to fall, an x-ray was taken, and the cut-out was found.
However, the patient had dementia and it was unknown if the cut-out occurred when the patient fell or for any other reason.
On (b)(6) 2022, the removal surgery of tfna was performed.
The removal surgery was completed successfully with no surgical delay.
Since the patient is a wheelchair user, and in the future, conservative treatment will be kept if the patient does not have pain, and tha will be performed if the patient has pain.
No further information is available.
This complaint involves one (1) device tfna helical blade l95 tan.
This is report 1 of 1 for complaint (b)(4).
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