MalfunctionISH
ICELOCK 621 RATCHET
Received Feb 16, 2024 · Event occurred Dec 28, 2023
Report 3008523132-2024-00001 · MDR key 18721707
Product problems
- Naturally Worn
- Naturally Worn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED THROUGH CAPA TO IMPROVE PRODUCT PERFORMANCE. UNHARDENED GUIDE PLATE CONTRIBUTED TO PREMATURE WEAR OF LOCK. ALL COMPONENTS IN THE LOCK MECHANISM ARE NOW HARDENED DURING MANUFACTURING. LOT NUMBER MX211022 WAS PART OF FSCA #(B)(4) WHICH HAD BEEN IMPLEMENTED IN 2023.
Description of Event or Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE LOCK WAS NOT FUNCTIONING PROPERLY AFTER 1 MONTH IN USE (NORMAL USAGE). THERE WAS NO INDICATION OF AN INCIDENT, FALL OR INJURY.