ICELOCK 621 RATCHET
Received Mar 15, 2023
Report 3003764610-2023-00013 · MDR key 16546126
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
THE LOCK IS NO LONGER HOLDING THE PIN SECURELY.
Additional Manufacturer Narrative
PRODUCT HAD BEEN IN USE FOR LESS THAN 5 MONTHS WHEN COMPLAINT WAS FILED DUE TO LOCK/RELEASE FAILURE. PATIENT DID NOT FALL OR SUSTAIN INJURIES. LOCKING PLATE WAS WORN, PIN WAS NOT RETURNED. CAPA IS IN PROGRESS TO ADDRESS ISSUES WITH PREMATURE WEAR OF THE LOCK. PREMATURE WEAR 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.