MalfunctionGDG
WECK DURAHOOK 1/4" HOOK 10 PKG/BX 6 HKS/PKG
Received May 14, 2013 · Event occurred May 2, 2013
Report 3003898360-2013-00201 · MDR key 3123726
Device
Product problems
- Break
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
DEVICE SAMPLE NOT RECEIVED BY MANUFACTURER. A DEVICE HISTORY RECORD (DHR) REVIEW DID NOT SHOW ANY ISSUES RELATED TO THIS COMPLAINT. COMPLAINT NOT CONFIRMED. A ROOT CAUSE CAN NOT BE DETERMINED SINCE THE SAMPLE WAS NOT AVAILABLE. MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.
Description of Event or Problem
THE EVENT IS REPORTED AS: "CUSTOMER CALLED REPORTING THAT THE RUBBER BANDS WERE CRUMBLING. THEY WERE BREAKING WHILE THE OPERATING ROOM STAFF WAS PREPARING TO USE THEM. THERE WAS NO PATIENT INVOLVEMENT."