MalfunctionISH
ICELOCK 621 RATCHED
Received Mar 3, 2023 · Event occurred Jul 26, 2022
Report 3003764610-2023-00005 · MDR key 16477446
Product problems
- Naturally Worn
- Naturally Worn
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE USER REPORTED THE DEVICE FALLING OFF WHILE WALKING OUTSIDE. NO INJURY OCCURRED.
Additional Manufacturer Narrative
PRODUCT FAILED WHEN PIN CAME LOOSE FROM LOCK WHEN USER WAS WALKING OUTSIDE. PRODUCT HAD BEEN IN USE FOR 4 MONTHS. MINOR WEAR WAS IDENTIFIED ON LOCKING PLATE AND LOCKING PINS. PRODUCT WEAR IS A KNOWN DISADVANTAGE WITH RATCHET LOCK WHERE UNHARDENED GUIDE PLATE MAY HAVE BEEN MORE SUSCEPTIBLE TO A BINDING EFFECT BETWEEN SIMILAR STAINLESS-STEEL MATERIAL AND SUBSEQUENT FASTER WEAR DOWN. CAPA IS IN PROGRESS AND IMPROVEMENTS HAVE BEEN IMPLEMENTED.