ICELOCK 621 RATCHET
Received Mar 3, 2023 · Event occurred Jan 30, 2023
Report 3003764610-2023-00007 · MDR key 16478029
Product problems
- Naturally Worn
- Naturally Worn
Patient
Unknown
- Blister
- Blister
Narrative
Description of Event or Problem
LOCK WAS CLICKING FOR A COUPLE OF DAYS, THEN ONE DAY STOPPED ENGAGING WITH THE PIN, PIN RELEASED FROM SOCKET AND WOULD NOT STAY ON. CUSTOMER REPORTED THAT PATIENT HAD TO HOBBLE AROUND AND GOT A BLISTER AT THE BOTTOM OF THE RESIDUAL LIMB.
Additional Manufacturer Narrative
PREMATURE PRODUCT WEAR RESULTED IN LOCK NOT PROVIDING SECURE SUSPENSION. PRODUCT HAD BEEN IN USE FOR 4 MONTHS. USER DEVELOPED SKIN REACTION ON THE RESIDUAL LIMB FROM HOBBLING AROUND WHILE ON HOLIDAY. PLAY AND PREMATURE LOCKING PLATE WEAR HAS BEEN IDENTIFIED AS LIKELY ROOT CAUSE OF FAILURE. 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.
Description of Event or Problem
LOCK WAS CLICKING FOR A COUPLE OF DAYS, THEN ONE DAY STOPPED ENGAGING WITH THE PIN, PIN RELEASED FROM SOCKET AND WOULD NOT STAY ON. CUSTOMER REPORTED THAT PATIENT HAD TO HOBBLE AROUND AND GOT A BLISTER AT THE BOTTOM OF THE RESIDUAL LIMB.
Description of Event or Problem
LOCK WAS CLICKING FOR A COUPLE OF DAYS, THEN ONE DAY STOPPED ENGAGING WITH THE PIN, PIN RELEASED FROM SOCKET AND WOULD NOT STAY ON. CUSTOMER REPORTED THAT PATIENT HAD TO HOBBLE AROUND AND GOT A BLISTER AT THE BOTTOM OF THE RESIDUAL LIMB.