ICELOCK 621 RATCHET
Received Jan 19, 2023 · Event occurred Nov 24, 2022
Report 3003764610-2023-00003 · MDR key 16205836
Product problems
- Detachment of Device or Device Component
- Naturally Worn
- Detachment of Device or Device Component
- Naturally Worn
Patient
Unknown
- Limb Fracture
- Limb Fracture
Narrative
Description of Event or Problem
PATIENT WAS WALKING WHEN THE PIN RELEASED FROM THE LOCK IN THE PROSTHETIC SOCKET AND PATIENT LIFTED OUT OF THE SOCKET. THE PATIENT SUFFERED A BROKEN WRIST.
Additional Manufacturer Narrative
LOCK FAILED TO PROVIDE SECURE SUSPENSION RESULTING IN USER FALLING SUSTAINING FRACTURED SCAPHOID. PRODUCT HAD BEEN IN USE FOR 1 YEAR. THE LOCKING PLATE WAS FOUND WORN BUT PIN WAS NOT RETURNED. LOCK HAVING BEEN USED WITH ALREADY WORN PIN HAS BEEN IDENTIFIED AS LIKELY ROOT CAUSE OF FAILURE AS IT MAY LEAD TO EARLY BREAKDOWN OF THE LOCKING PLATE.
Description of Event or Problem
PATIENT WAS WALKING WHEN THE PIN RELEASED FROM THE LOCK IN THE PROSTHETIC SOCKET AND PATIENT LIFTED OUT OF THE SOCKET. THE PATIENT SUFFERED A BROKEN WRIST.