ICELOCK 621 RATCHED
Received Mar 6, 2023 · Event occurred Dec 31, 2022
Report 3003764610-2023-00008 · MDR key 16485802
Product problems
- Unintended Ejection
- Naturally Worn
- Unintended Ejection
- Naturally Worn
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PATIENT WAS WALKING AND PIN RELEASED FROM LOCK WITHOUT WARNING. NO INJURY OCCURRED.
Additional Manufacturer Narrative
LOCK FAILED TO PROVIDE SECURE SUSPENSION WHEN USER WAS WALKING, USER DID NOT FALL OR SUSTAIN ANY INJURIES BUT SHOULD A SIMILAR INCIDENT RECUR THERE IS A POSSIBILITY OF INJURY. PRODUCT HAD BEEN IN USE FOR 1 YEAR. LOCK WAS TESTED WITH A NEW PIN AND FOUND TO ENGAGE PIN SUCCESSFULLY. MINOR WEAR WAS IDENTIFIED ON LOCKING PLATE AND GUIDE PLATE DURING INSPECTION. DIRT WAS IDENTIFIED IN LOCKING MECHANISM WHEN LOCK WAS DISASSEMBLED. IT IS POSSIBLE THAT WORN ATTACHMENT PIN RESULTED IN PIN RELEASING FROM LOCK. UNABLE TO CONCLUDE ON ROOT CAUSE SINCE THE ATTACHMENT PIN WAS NOT RETURNED WITH THE LOCK.
Description of Event or Problem
PATIENT WAS WALKING AND PIN RELEASED FROM LOCK WITHOUT WARNING. NO INJURY OCCURRED.