ICELOCK 621 RATCHET
Received Mar 15, 2023 · Event occurred Feb 20, 2023
Report 3003764610-2023-00012 · MDR key 16545355
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
IN JANUARY THE SOCKET LOCK JAMMED AND PATIENT WAS STUCK IN THE PROSTHESIS. SOCKET LOCK WAS REMOVED AND REPAIRED. PRODUCT FAILED AGAIN (B)(6) 2023 AS LOCK WAS NOT HOLDING PIN RESULTING IN NO SUSPENSION. LOCK WAS REPLACED. NO INJURY OCCURRED.
Additional Manufacturer Narrative
PRODUCT HAD BEEN IN USE FOR 6 MONTHS WHEN COMPLAINT WAS FILED DUE TO LOCK/RELEASE FAILURE. PATIENT DID NOT FALL OR SUSTAIN INJURIES. LOCKING PLATE WAS HIGHLY WORN AND TOP NOTCH ON PIN WORN. 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.