CORKSCREW II SUTURE ANCHOR, 5X15MM
Received Nov 14, 2007 · Event occurred Sep 11, 2007
Report 1220246-2007-00248 · MDR key 946514
Device
Generic name
Suture Anchor Device
Manufacturer
Arthrex, Inc.Model number
NACatalog number
AR-1902SF
Lot number
94323
Product problems
- Device remains implanted
Patient
YR
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, A DEFINITIVE CONCLUSION COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE. DEVICE HISTORY REVIEW REVEALED NO ISSUES WITH THE STERILIZATION OF THIS LOT. THIS IS THE FIRST OF THREE SIMILAR INCIDENTS OF THIS NATURE FOR THIS PART FROM THE SAME SURGEON/HOSPITAL. BASED ON PREVIOUS EVALUATIONS, INFECTION CASES ARE USUALLY HOSPITAL ACQUIRED, NOT A PRODUCT RELATED ISSUE. THE TYPE OF INFECTION FOUND IN THE PATIENT REMAINS UNKNOWN.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN UNKNOWN INFECTION IN THE SHOULDER POST MINI-OPEN ROTATOR CUFF REPAIR. INFORMATION REGARDING THE TYPE OF INFECTION, AND PATIENT CONDITION WAS REQUESTED WITHOUT SUCCESS. THIS DEVICE IS USED FOR TREATMENT.