XL CMI - MEDIAL
Received Jul 1, 2019 · Event occurred Jun 11, 2019
Report 0002936485-2019-00267 · MDR key 8751215
Device
Generic name
Scaffold, Partial Medial Meniscal Defects Extending Into The Red/white Zone, Re
Manufacturer
Stryker Endoscopy-san JoseCatalog number
4612
Lot number
18E535
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ALLEGED FAILURE: IMPLANT BROKE DURING INSERTING. THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. 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 PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE BROKE. ADDITIONAL INFORMATION CONFIRMED NO PIECES WERE LEFT FLOATING IN THE JOINT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. PMA/ 510(K) NUMBER WILL BE SUPPLIED IN THE FOLLOW UP REPORT.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE BROKE. ADDITIONAL INFORMATION CONFIRMED NO PIECES WERE LEFT FLOATING IN THE JOINT.