CMI - LATERAL
Received May 8, 2019 · Event occurred Apr 10, 2019
Report 0002936485-2019-00195 · MDR key 8592779
Device
Generic name
Scaffold, Partial Medial Meniscal Defects Extending Into The Red/white Zone, Res
Manufacturer
Stryker Endoscopy-san JoseCatalog number
4607
Lot number
18F538
Product problems
- Break
Patient
37 YR
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: CHOUROUK MERDJA FROM THE HOSPITAL REPORTED THE FOLLOWING EVENT : " DURING AN OPERATION FOR THE TREATMENT OF EARLY GONARTHROSIS, A FAILURE TO PLACE THE LATERAL MENISCAL IMPLANT FOLLOWING ITS FAILURE WAS NOTED. OPERATORS REPORTED THAT THE IMPLANT HAD BROKEN DURING REMOTE PLACEMENT OF THE GRIPPING SITE. FOLLOWING THIS INCIDENT, THE SURGEON FINALIZED THE PROCEDURE BY IMPLANTING ONLY THE MEDIAL IMPLANT. " THE PROBABLE ROOT CAUSES COULD BE: 1) EXCESSIVE FORCE APPLIED ON CMI, 2) USER INADEQUATELY PREPARED CMI FOR REPAIR, OR 3) USER OVER-CLAMPS IMPLANT. THE DEVICE MANUFACTURE DATE IS NOT KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT THE PRODUCT BROKE. IT WAS NOT CONFIRMED IF ALL THE BROKEN PIECES WERE RETRIEVED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS.
Description of Event or Problem
IT WAS REPORTED THAT THE PRODUCT BROKE. IT WAS NOT CONFIRMED IF ALL THE BROKEN PIECES WERE RETRIEVED.