MalfunctionISH
ICELOCK 621 RATCHED
Received Mar 3, 2023 · Event occurred Sep 22, 2022
Report 3003764610-2023-00006 · MDR key 16477447
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 COMING OFF WHILE CLIMBING STAIRS. NO INJURY OCCURRED.
Additional Manufacturer Narrative
LOCK FAILED TO PROVIDE SECURE SUSPENSION RESULTING IN DEVICE COMING OFF WHILE USER WAS CLIMBING STAIRS. PRODUCT HAD BEEN IN USE FOR 4 MONTHS. THE LOCKING PLATE AND LOCKING PINS WERE FOUND WORN. 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 PRODUCT IMPROVEMENTS HAVE BEEN IMPLEMENTED.