STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, STST GAMMA3 11X180MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
|
Back to Search Results |
|
Catalog Number 41251180S |
Device Problems
Positioning Failure (1158); Failure to Align (2522)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/21/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Upon completion of investigation, additional information will be provided in a supplemental report.
|
|
Event Description
|
The customer (dr.(b)(6)) has reported the following event: "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 (b)(6).".
|
|
Manufacturer Narrative
|
Corrections: please refer to section h6 (device code and health impact code).The reported event could be confirmed, since the returned set screw is stuck within the nail.The device inspection revealed the following: visual inspection: we received a nail kit [consists of nail and set screw] for evaluation.The returned nail and set screw was received in assembled condition.After disassembling the set screw becomes visible with signs of damage at the thread and blood and tissue residues.After cleaning steps performed, microscopic evaluation revealed obvious damaged windings [flattened] due to slight oblique insertion.Functional inspection: initially the set screw inserted in the nail was impossible to move with « normal forces » - neither in nor out.Through applied high forces with a locking screw as counterpart ¿ after a ¿click¿ ¿ the set screw loosened.The returned nail and set screw was disassembled.A sample set screw could be inserted into one of the four grooves of the lag screw returned; the requirements of preventing both rotation and complete migration of the lag screw and sliding in a limited and defined range were fulfilled as intended.Dimensional inspection: correct dimensions of the nail were confirmed by above mentioned functional check.Due to the nature of the returned set screw, a dimensional inspection was not possible.Based on the above facts it can be ascertained that the root cause is not related to a deficiency of the device but is rather linked to an inadequate handling by the user.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.
|
|
Event Description
|
The customer (dr.(b)(6)) has reported the following event: "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
|
|
|