ICELOCK 621 RATCHET
Received Apr 5, 2023 · Event occurred Mar 30, 2023
Report 3008523132-2023-00003 · MDR key 16680827
Device
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 STARTED TO ALLOW THE PIN TO SLIP OUT WHEN WALKING. THE PATIENT DID NOT FALL OR SUSTAIN ANY INJURY.
Additional Manufacturer Narrative
PRODUCT REQUIRED ANALYSIS DUE TO A SUDDEN LOCKING FAILURE. PRODUCT HAD BEEN IN USE FOR 1 YEAR. PATIENT DID NOT FALL OR SUSTAIN OTHER INJURIES. PRODUCT WAS TESTED AND IT DID NOT HOLD THE ATTACHMENT PIN, BOTH ATTACHMENT PIN AND LOCKING PLATE ARE WORN. CAPA IS IN PROGRESS TO ADDRESS ISSUES WITH PREMATURE WEAR OF LOCK. 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.