Catalog Number 623-00-32D |
Device Problems
Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Date 09/15/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
|
|
Event Description
|
A hair was found in the package.
|
|
Manufacturer Narrative
|
An event regarding foreign matter involving a trident liner was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection of the returned device noted the following: visual inspection was completed on the returned part.The part was returned inside the opened blister.The blister is blood spattered and a hair (appears to be an eyelash) can be seen on the poly liner.The liner also has some traces of blood on its surface.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that a hair was found in the package of the trident liner, it is noted that the packaging was opened at the time of discovery.Hence, the event cannot be confirmed as happening prior to the opening of the sealed blister and the exact cause of the event could not be determined because insufficient information was provided.Further information such as images of the device prior to opening are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
|
|
Event Description
|
A hair was found in the package.Update: "1.Was this procedure a primary implantation of stryker devices? yes.If not, were stryker devices being revised? na.Was the patient in the operating room.At the time of event? yes.If so, was the patient under anesthesia? yes.Was the packaging opened? yes.Was the device removed from the packaging? no.Please estimate any surgical delay, even if under a minute (or indicate ¿none¿ to confirm there was absolutely no delay): 5 mins".
|
|
Search Alerts/Recalls
|