inforMED
MalfunctionISH

ICELOCK 621 RATCHET

Received Nov 18, 2024 · Event occurred Aug 30, 2024

Report 3003764610-2024-00008 · MDR key 20706662

Device

Generic name

Prosthetic Lock

Manufacturer

Ossur Hf

Model number

L-621000

Lot number

MX220316

Product problems

  • Degraded
  • Degraded

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

LOCK FAILED TO PROVIDE SECURE SUSPENSION RESULTING IN DISSATISFACTION FROM THE USER. UNHARDENED GUIDE PLATE LIKELY CONTRIBUTED TO PREMATURE WEAR OF LOCK. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO IMPROVE PRODUCT PERFORMANCE. ALL COMPONENTS IN THE LOCK MECHANISM ARE NOW HARDENED DURING MANUFACTURING. RECALL FOR AFFECTED LOTS OF ICELOCK RATCHET 621 DEVICE HAS BEEN COMPLETED, HOWEVER THE CUSTOMER IN QUESTION FILLED OUT A FORM ACKNOWLEDGING THE ISSUE BUT STILL DID NOT REPLACE THE LOCK AND PIN AS WAS REQUESTED IN THE NOTICE. NO FURTHER ACTION IS CONSIDERED WARRANTED.

Description of Event or Problem

LOCK FAILED TO PROVIDE SECURE SUSPENSION RESULTING IN DISSATISFACTION FROM THE USER.