MalfunctionGZT
CASPER RETRACTOR, F,/BV460R, OR BV460T
Received May 9, 2003
Report 2916714-2003-00016 · MDR key 459872
Device
Product problems
- Fracture
- Material Separation
- Component Missing
Patient
UNKNOWN
- Surgery, prolonged
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
INITIAL REPORT: DURING A CASE, IT WAS DISCOVERED THAT A SCREW WAS MISSING. IT COULD NOT BE DETERMINED WHEN THE INSTRUMENT FRACTURED. AFTER THE INSTRUMENT WAS NOTED TO BE FRACTURED, X-RAYS WERE TAKEN. SURGERY WAS EXTENDED APPROXIMATELY TWENTY MINUTES. THE INITIAL REPORTER WAS CONTACTED. THE REPORTER ASSUMES THAT THE SCREW WAS NOT LOCATED. THE REPORTER DID NOT HAVE ANY ADDITIONAL INFORMATION AND REQUESTED THAT COMPANY CONTACT THE RISK MANAGER. THE RISK MANAGER WAS CONTACTED, BUT COULD NOT PROVIDE ANY ADDITIONAL INFORMATION.