ICELOCK 621 RATCHED
Received Mar 13, 2023 · Event occurred Dec 13, 2022
Report 3003764610-2023-00010 · MDR key 16530131
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
GRADUAL ISSUE, INITIALLY LOCK WAS REPORTED TO BE WORKING INTERMITTENTLY AND WAS SERVICED. ONE WEEK LATER THE LOCK WAS NOT HOLDING THE PIN AT ALL AND WAS REPLACED.
Additional Manufacturer Narrative
PRODUCT HAD BEEN IN USE FOR 6 MONTHS WHEN COMPLAINT WAS FILED DUE TO LOCK/RELEASE FAILURE. PATIENT STUMBLED BUT DID NOT FALL OR SUSTAIN INJURIES. PRODUCT WAS NOT RETURNED FOR INVESTIGATION SINCE IT HAD BEEN DISCARDED. UNHARDENED GUIDE PLATE LIKELY CONTRIBUTED TO PREMATURE WEAR OF LOCK, 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. THE MAJORITY OF CLAIMS REGARDING THIS ISSUE WERE NOT ASSOCIATED WITH AN INCIDENT, BUT DISCOVERED IN A TIMELY MANNER.