ICELOCK 621 RATCHET
Received Jul 18, 2023 · Event occurred Jun 27, 2023
Report 3008523132-2023-00008 · MDR key 17342003
Device
Product problems
- Insufficient Device Problem Information
- Misassembled During Installation
- Insufficient Device Problem Information
- Misassembled During Installation
Patient
Unknown
- Laceration(s)
- Laceration(s)
Narrative
Additional Manufacturer Narrative
AN EVENT OCCURRED AND HAS LED TO MODERATE INJURY. THE ROOT CAUSE WAS FOUND TO BE INSTALLATION RELATED, NO INDICATION OF MATERIAL OR MANUFACTURING FAILURE HAS BEEN FOUND. GENERAL SAFETY INSTRUCTIONS IN THE IFU STATE THAT USER SHOULD ENSURE THAT THE PIN IS FULLY ENGAGED. IFU WARNS USERS THAT EXTENDED USE OF THE DEVICE WITHOUT FULL ENGAGEMENT MAY AFFECT SAFETY AND PERFORMANCE OF THE DEVICE.
Description of Event or Problem
THE PROSTHESIS DETACHED FROM THE STUMP, THE PATIENT FELL AND GOT A LACERATION ON THE LEG WHICH REQUIRED STITCHES.
Description of Event or Problem
THE PROSTHESIS DETACHED FROM THE STUMP, THE PATIENT FELL AND GOT A LACERATION ON THE LEG WHICH REQUIRED STITCHES.