ICELOCK 621 RATCHET
Received Apr 5, 2023 · Event occurred Mar 13, 2023
Report 3008523132-2023-00002 · MDR key 16680633
Device
Product problems
- Naturally Worn
- Naturally Worn
Patient
Unknown
- Limb Fracture
- Limb Fracture
Narrative
Additional Manufacturer Narrative
PRODUCT HAD BEEN IN USE FOR 1 YEAR WHEN COMPLAINT WAS FILED DUE TO LOCK/RELEASE FAILURE. USER FELL AND SUSTAINED A BROKEN ELBOW. THE LOCKING PLATE AND LOCKING PIN WERE FOUND WORN SO PIN WOULD RELEASE FROM LOCK WITHOUT PRESSING THE RELEASE MECHANISM WHEN NOT FULLY ENGAGED. PRODUCT WEAR IS A KNOWN DISADVANTAGE WITH RATCHET LOCK WHERE UNHARDENED GUIDE PLATE AND HARDNESS DIFFERENCES BETWEEN LOCKING PIN AND LOCKING PLATE MAY HAVE BEEN MORE SUSCEPTIBLE TO A BINDING EFFECT BETWEEN SIMILAR STAINLESS-STEEL MATERIAL AND SUBSEQUENT FASTER WEAR DOWN. CAPA IS IN PROGRESS TO ADDRESS ISSUES WITH PREMATURE WEAR OF THE LOCK. USER HAD HAD ISSUES WITH PIN COMING LOOSE 4 TIMES IN THE DAYS PRIOR TO INJURY. INSTRUCTIONS FOR USE FOR THE DEVICE INCLUDES A WARNING THAT IF THERE IS CHANGE IN OR LOSS IN DEVICE FUNCTIONALITY, THE USER SHOULD STOP USING THE DEVICE AND CONTACT A HEALTHCARE PROFESSIONAL. THE MAJORITY OF COMPLAINTS REGARDING THIS ISSUE WERE NOT ASSOCIATED WITH AN INCIDENT, BUT DISCOVERED IN A TIMELY MANNER.
Description of Event or Problem
THE PATIENT WAS WALKING TO WORK, AND THE PROSTHESIS CAME OFF AND HE FELL. HE WAS INJURED, SUFFERING BRUISING TO THE STUMP AND A FRACTURED ELBOW.