MalfunctionHSH
SCORPIO TIBIAL BASEPLATE
Received Apr 12, 2012 · Event occurred Mar 30, 2012
Report 2249697-2012-00435 · MDR key 2557680
Device
Generic name
Implant
Manufacturer
Stryker Orthopaedics MahwahModel number
NACatalog number
7115-00X
Lot number
UNK
Product problems
- Sticking
Patient
UNK
- No Information
Narrative
Description of Event or Problem
ND FROM DISTRIBUTOR (B)(4) REPORTED ON BEHALF OF THE CUSTOMER THAT WHEN THE NURSES PULL OFF THE TOP SEAL IT REGULARLY DOES NOT COME OFF CLEANLY, BUT LEAVE STRIPS ATTACHED. THEY ADDED THAT SOMETIMES WHEN THEY OPEN THE INNER SEAL, THE FOAM INSERT STICKS TO THE SEAL.
Additional Manufacturer Narrative
ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Remedial action
- Other