ICELOCK 621 RATCHET
Received Oct 6, 2022
Report 3003764610-2022-00003 · MDR key 15549705
Product problems
- Naturally Worn
- Naturally Worn
Patient
Unknown
- Tooth Fracture
- Tooth Fracture
Narrative
Description of Event or Problem
THE PATIENT REPORTED THAT THE LOCK MECHANISM SPONTANEOUSLY FAILED, WHICH CAUSED THE PROSTHETIC LIMB TO FALL OFF AND THEN HIM TO FALL. IN THE FALL HE HIT THE KITCHEN WORKTOP WHICH CAUSED TWO TEETH TO BE KNOCKED OUT.
Additional Manufacturer Narrative
PREMATURE PRODUCT WEAR RESULTED IN LOCK NOT PROVIDING SECURE SUSPENSION. A CHANGE WAS MADE IN 2021 TO THE GUIDE PLATE WHICH GUIDES THE LOCKING PIN INTO THE LOCK, WHERE THE HARDENING PROCEDURE WAS ABANDONED. THIS EFFECTIVELY MADE THE GUIDE PLATE MORE SUSCEPTIBLE TO A BINDING EFFECT BETWEEN SIMILAR STAINLESS-STEEL MATERIAL AND SUBSEQUENT FASTER WEAR DOWN. THE DESIGN CHANGE HAS BEEN REVERTED. LIKELIHOOD OF FAILURE TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE FAILURE WERE TO RECUR IS STATED AS "REMOTE" AS THIS CASE IS THE ONLY INCIDENT REPORTED WHERE FAILURE RESULTED IN SERIOUS INJURY. ISSUE IS EXPECTED TO BE DISCOVERED BY THE USER BEFORE BECOMING HAZARDOUS AS WEAR OCCURS GRADUALLY OVER TIME AND A CHANGE IN USE OF THE LOCKING MECHANISM IS LIKELY TO BE NOTICED BY THE USER.
Description of Event or Problem
THE PATIENT REPORTED THAT THE LOCK MECHANISM SPONTANEOUSLY FAILED, WHICH CAUSED THE PROSTHETIC LIMB TO FALL OFF AND THEN HIM TO FALL. IN THE FALL HE HIT THE KITCHEN WORKTOP WHICH CAUSED TWO TEETH TO BE KNOCKED OUT.