STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP DUAL CUT SAGITTAL BLADE (25 X 90 X 1.37MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
|
Back to Search Results |
|
Model Number 4125137090 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/01/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
A follow up report will be filed once the quality investigation is complete.
|
|
Event Description
|
It was reported that there was a potential sterility breach on the packaging of the device, prior to a procedure, small holes were found in the pack.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
|
|
Event Description
|
It was reported that there was a potential sterility breach on the packaging of the device, prior to a procedure, small holes were found in the pack.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
|
|
Manufacturer Narrative
|
H6: the quality investigation is complete.
|
|
Search Alerts/Recalls
|
|
|