ICELOCK 621 RATCHET
Received Apr 13, 2023 · Event occurred Dec 12, 2022
Report 3008523132-2023-00005 · MDR key 16732794
Device
Product problems
- Naturally Worn
- Naturally Worn
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PRODUCT HAD BEEN IN USE FOR 6 MONTHS WHEN IT FAILED. PRODUCT WILL NOT BE RETURNED. NO INDICATION OF USER FALLING OR SUSTAINING ANY INJURIES. CAPA IS IN PROGRESS TO ADDRESS ISSUES WITH PREMATURE WEAR OF LOCK. PREMATURE WEAR OF COMPONENTS COULD LEAD TO A SERIOUS INJURY BUT ISSUE IS EXPECTED TO BE DISCOVERED BY THE USER BEFORE BECOMING HAZARDOUS AS WEAR OCCURS GRADUALLY OVER TIME AND A CHANGE IN USE OF THE LOCKING MECHANISM IS LIKELY TO BE NOTICED BY THE USER. IFU INCLUDES A WARNING FOR CHANGE OR LOSS IN DEVICE FUNCTIONALITY, AND TO CONTACT A CLINICIAN WHEN THIS OCCURS. THE MAJORITY OF COMPLAINTS REGARDING THIS ISSUE WERE NOT ASSOCIATED WITH AN INCIDENT, BUT DISCOVERED IN A TIMELY MANNER.
Description of Event or Problem
MECHANISM WORN OUT AFTER 6 MONTHS USE. NO INJURY OCCURRED.