MalfunctionKGS
STATAK SOFT TISSUE ATTACHMENT DEVICE
Received Aug 1, 2008 · Event occurred Jun 24, 2008
Report 1822565-2008-00471 · MDR key 1095332
Device
Generic name
Suture Attachment Device
Manufacturer
Zimmer, Inc.Model number
NACatalog number
00234407200
Lot number
UNK
Product problems
- Break
Patient
UNK
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING SURGERY IN 2008, THE SUTURE COULD NOT BE PULLED OUT FROM THE SHAFT PART. THE SURGERY WAS FINISHED USING THE SUTURE IN WHICH ONLY A FEW CAME OUT FROM THE SHAFT.
Additional Manufacturer Narrative
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.