MalfunctionGDF
CODMAN CRILE-WOOD NEEDLE HOLDER
Received Nov 27, 2013 · Event occurred Nov 14, 2013
Report 3007208013-2013-00017 · MDR key 3544732
Device
Generic name
Crile-wood Needle Holder
Manufacturer
Symmetry Surgical Inc.Model number
36-2000Catalog number
36-2000
Lot number
HC31 1010
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE NEEDLE HOLDER HANDLE WAS SEVERED AT THE FULCRUM. THE COMPLAINANT SAID IT WAS USED DURING A PROCEDURE WHEN IT BROKE. (B)(6) HOSPITAL REPORTED THAT NO PT WAS HARMED AS A RESULT TO THE BREAKAGE.
Additional Manufacturer Narrative
PRODUCT WAS REPAIRED IN 07/2012 PRIOR TO SYMMETRY SURGICAL PURCHASE OF CODMAN INSTRUMENTS.
Remedial action
- Replace