inforMED
MalfunctionKGS

STATAK SOFT TISSUE ANCHOR

Received Nov 28, 2012 · Event occurred Oct 9, 2012

Report 1822565-2012-02428 · MDR key 2861540

Device

Generic name

Soft Tissue Anchor

Manufacturer

Zimmer, Inc.

Catalog number

00234405000

Lot number

291338

Product problems

  • Appropriate Device Problem Term/Code Not Available

Patient

20 YR

  • No Information

Narrative

Description of Event or Problem

IT IS REPORTED THAT THE SURGEON INSERTED THE ANCHOR INTO THE PT'S HAND, AND THEN NOTICED THERE WAS NO SUTURE ATTACHED TO IT. THE SURGEON REMOVED THE ANCHOR AND FINISHED THE PROCEDURE WITH A NEW ANCHOR.

Additional Manufacturer Narrative

THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.