MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
Received Aug 16, 2012 · Event occurred Jul 19, 2012
Report 1030489-2012-01395 · MDR key 2703094
Device
Generic name
Screwdriver
Manufacturer
Medtronic Sofamor Danek Usa, IncModel number
NACatalog number
8350316
Product problems
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN L4-5 POSTERIOR LUMBAR INTERBODY FUSION TO TREAT LSCS. IT WAS REPORTED THAT AFTER BREAK OFF OF THE SETSCREW TABS WAS ACHIEVED 5 TABS CAME OUT OF THE DRIVER, ALTHOUGH ONLY 4 SCREWS WERE BROKEN. IT IS BELIEVED THAT THE EXTRA TAB CAME FROM A PREVIOUS SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED.
Additional Manufacturer Narrative
THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE LOT # GB10M001, #GB11F011, # GB11G008 AND # GB11J011. (B)(6). (B)(4). MANUFACTURE DATE FOR LOT GB11M001 IS 12/13/10; LOT GB11F011 IS 7/18/11; LOT GB11G008 IS 8/8/11; LOT GB11J011 IS 10/5/11. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.