inforMED
MalfunctionKGS

ORTHOPEDIC BIOSYSTEMS LTD

Received Oct 29, 1998 · Event occurred Oct 21, 1998

Report MW1014871 · MDR key 194773

Device

Generic name

Tissue Anchor

Model number

ANCHOR RC5

Catalog number

*

Lot number

*

Product problems

  • Material Fragmentation
  • Difficult to Remove
  • Replace
  • Unstable
  • Failure to Advance

Patient

33 YR

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

SURGICAL PROCEDURE, REPAIR LEFT TORN PECTORALIS MUSCLE. SURGEON WAS UNABLE TO ADVANCE THE ANCHOR FAR ENOUGH INTO BONE TO PROVIDE ADEQUATE STABILIZATION. ATTEMPTED SEVERAL TIMES TO REMOVE ANCHOR. EVENTUALLY WAS ABLE TO REMOVE ANCHOR, HOWEVER SMALL FRAGMENTS CAME OFF DURING REMOVAL. SURGEON FELT SECURE THAT ENTIRE ANCHOR WAS REMOVED FROM PT.