ICELOCK 621 RATCHET
Received Nov 1, 2023 · Event occurred Sep 7, 2023
Report 3003764610-2023-00017 · MDR key 18048303
Product problems
- Naturally Worn
- Naturally Worn
Patient
Unknown
- Bruise/Contusion
- No Clinical Signs, Symptoms or Conditions
- Bruise/Contusion
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
LOCK FAILED TO PROVIDE SECURE SUSPENSION RESULTING IN THE USER FALLING AND SUSTAINING MINOR INJURIES. PRODUCT HAD BEEN IN THE FIELD FOR 51 MONTH BUT PRODUCT USAGE TIME IS UNKNOWN. LIKELY THE LOCKING PLATE AND ATTACHMENT PIN WERE WORN SO ATTACHMENT PIN WOULD RELEASE WITHOUT PRESSING THE RELEASE MECHANISM. PRODUCT WEAR IS A KNOWN DISADVANTAGE AS SLOW WEAR IN THE LOCKING PLATE CAN LEAD TO THE LOCK NOT PROVIDING SUPPORT IF EITHER FAILS.
Description of Event or Problem
WHILE WALKING THE PIN CAME OUT OF THE LOCK AND THE PROSTHETIC LIMB FELL OFF. THE PATIENT FELL BACKWARDS TO THE FLOOR.
Description of Event or Problem
WHILE WALKING THE PIN CAME OUT OF THE LOCK AND THE PROSTHETIC LIMB FELL OFF. THE PATIENT FELL BACKWARDS TO THE FLOOR BUT WAS NOT INJURED.
Remedial action
- Replace