MalfunctionISH
KIT ROTATE TALL FEM C6 S27
Received Apr 7, 2014 · Event occurred Mar 7, 2014
Report 3003764610-2014-00001 · MDR key 3793458
Device
Product problems
- Material Separation
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
UPON FAILURE ANALYSIS INVESTIGATION PERFORMED ON (B)(6) 2014 - IT WAS DETERMINED THAT THIS IS A MDR REPORTABLE EVENT SINCE THIS RISK IS NOT ACCEPTABLE TO THE PT. NO INJURY OCCURRED WITH THIS INCIDENT, HOWEVER, CAPA (B)(4) WAS OPENED TO ADDRESS THIS RISK.
Description of Event or Problem
UPPER SECTION, ROTATE AND CLAMP SEPARATED FROM PROSTHETIC FOOT COMPLETELY.