ICELOCK 621 RATCHET
Received Apr 13, 2023 · Event occurred Mar 15, 2023
Report 3008523132-2023-00004 · MDR key 16731651
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
BROKEN LOCK WAS RETURNED BY THE CUSTOMER AFTER 3 MONTHS IN THE FIELD.
Additional Manufacturer Narrative
PRODUCT HAD BEEN IN USE FOR LESS THAN 3 MONTHS WHEN THE LOCK FAILED. PATIENT DID NOT FALL OR SUSTAIN 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. IFU INDICATES A WARNING FOR CHANGE OR LOSS IN DEVICE FUNCTIONALITY, AND TO CONTACT A CPO WHEN THIS OCCURS.