SMITH & NEPHEW, INC. GII P/S CONS HOUSING REAM DOME; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
|
Back to Search Results |
|
Catalog Number 71440145 |
Device Problem
Dull, Blunt (2407)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 05/14/2020 |
Event Type
Injury
|
Event Description
|
It was reported that before procedure the ps housing reamer dome found dull.An s+n backup device was available.No injuries or surgical delays were reported.
|
|
Manufacturer Narrative
|
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the event reported was not considered a reportable malfunction as the dull device was found before surgery, after a historical review it was also determined that no medical intervention had to be performed for similar failure modes of the same product family in the past, the reported failure mode is common occurrence expected from the normal wear and tear of the device caused from the extensive use of the device along the time, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
|
|
Search Alerts/Recalls
|
|
|