inforMED
MalfunctionHTO

CORING REAMER 8.0MM DISPOSABLE

Received Mar 10, 2006 · Event occurred Jan 24, 2006

Report 1017294-2006-00064 · MDR key 687056

Device

Generic name

Coring Reamer

Model number

NA

Catalog number

CR8848

Lot number

NA

Product problems

  • Explanted

Patient

41 YR

  • Surgical procedure
  • Foreign body, removal of

Narrative

Description of Event or Problem

DURING A ACL REPAIR A FOREIGN BODY WAS FOUND IN THE PATIENT'S KNEE. THIS IS BELIEVED TO BE A RESULT OF A PREVIOUS ACL REPAIR DONE ON THIS PATIENT. WAS REPORTED THE SURGEON REMOVED THE FOREIGN BODY AND COMPLETED THE SURGERY.