ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS MEDWATCH IS BEING RESCINDED. THE COMPLAINT WAS REVIEWED ON 05/05/2014 AND DETERMINED TO BE A DUPLICATE COMPLAINT OF AN EXISTING CATSWEB COMPLAINT MANAGEMENT SYSTEM COMPLAINT (B)(4). COMPLAINT (B)(4) WAS PREVIOUSLY REPORTED THROUGH MFR# 3003506883-2012-00168. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

THIS REPORT IS FOR AN UNKNOWN BLADE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

ATTORNEY ADVISED THAT A MALE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION OF THE LEFT PATELLA ON (B)(6) 2012. IN THE PLACEMENT OF THE LOCKING BOLT, THE BOLT BOUND UP AND COULD NOT BE REMOVED. IT WAS REPORTED THAT THE DOCTOR INSPECTED THE BACK TABLE WHICH SHOWED METAL SHAVINGS WHERE THE LOCKING BOLT AND NAIL WERE ORIGINALLY PLACED. THE SET SCREW WAS FULLY DEPLOYED OR DEPLOYED DISTALLY WHICH CAUSED BINDING OF THE BLADE THROUGH THE NAIL. DURING THE ATTEMPTED REMOVAL OF THE NAIL AND BOUND BLADE, THE LATERAL CORTEX OF THE PATIENT SPLIT APPROXIMATELY HALF THE LENGTH OF THE FEMUR. THIS IS REPORT 4 OF 4 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN BLADE.