ICELOCK 621 RATCHED
Received Mar 9, 2023 · Event occurred Jan 4, 2023
Report 3003764610-2023-00009 · MDR key 16511813
Product problems
- Naturally Worn
- Naturally Worn
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
LOCK FAILED AFTER 3 WEEKS USE, NO INJURY OCCURRED. 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. FAILING LOCK CAN LEAD TO SERIOUS INJURY, BUT ISSUE IS EXPECTED TO BE DISCOVERED BY THE USER BEFORE BECOMING HAZARDOUS AS THE WEAR OCCURS GRADUALLY OVER TIME AND CHANGE IN USE OF THE LOCKING MECHANISM IS LIKELY TO BE NOTICED BY THE USER. INSTRUCTIONS FOR USE INDICATES A WARNING FOR CHANGE OR LOSS IN DEVICE FUNCTIONALITY, AND TO CONTACT A CLINICIAN WHEN THIS OCCURS.
Description of Event or Problem
PRODUCT HAD BEEN IN USE FOR 3 WEEKS WHEN THE COMPLAINT WAS FILED DUE TO LOCK/RELEASE FAILURE. NO INJURY OCCURRED.