|
Catalog Number 40600095S |
Device Problem
Positioning Failure (1158)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/21/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The subject device is not cleared for sale in the u.
S.
, but a similar device is commercially available in the u.
S.
Upon completion of investigation, additional information will be provided in a supplemental report.
|
|
Event Description
|
The customer reported that: "i would like to ask you about a defective 125° short gamma nail.
I wanted to insert a short gamma nail this morning for a pertrochanteric fracture.
I encountered a problem with the nail locking screw.
The cervicocephalic screw was not locking with the proximal locking screw.
I mentioned a problem with the cervicocephalic screw.
Changing the cervicocephalic screw did not solve the problem.
I had to change the 125° short gamma nail, which solved the problem.
When testing the nail outside the patient, i found that the locking mechanism of the cervicocephalic screw did not work.
I kept the nail in my office in cannes.
".
|
|
Search Alerts/Recalls
|
|
|