N
Patient 1
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION SUMMARY: EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT. ADDITIONALLY, THE TIP OF THE DEVICE WAS IDENTIFIED AS CHIPPED. THE COMPLAINT CONSISTED OF (1) 242101000 IN-CONDL CHISEL 8X10X7 3/4 IN, LOT NUMBER S02015050 EXAMINATION OF THE SUBMITTED IN-CONDL CHISEL 8X10X7 3/4 IN CONFIRMED THE DEVICE WAS WORN. ADDITIONALLY, THE TIP OF THE DEVICE WAS IDENTIFIED AS CHIPPED. THE BROKEN OFF FRAGMENT WAS NOT RETURNED. THE INITIAL REPORTING STATED NO PIECES OF THE DEVICE WERE LEFT IN THE PATIENT. THE RADEL HANDLE HAS SCRATCHES AND DISCOLORATION EXPECTED WITH NORMAL USE OF THE INSTRUMENTS. WEAR MARKS WERE ALSO PRESENT. A COMPLAINT DATABASE SEARCH AGAINST PRODUCT CODE 242101000 FOUND SIMILAR REPORTED EVENTS. ADDITIONAL REPORTED EVENT WAS INVESTIGATED AND FOUND THE TIPS OF THE CHISELS WERE LOADED BEYOND THE MATERIAL LIMIT RESULTING IN MIXED MODE DUCTILE AND BRITTLE OVERLOAD OF THE MATERIAL AND FRACTURE. THE ROOT CAUSE IS ATTRIBUTED TO USER ERROR/TECHNIQUE. THE TIP OF THE CHISEL WAS LOADED BEYOND THE MATERIAL LIMIT RESULTING IN MIXED MODE DUCTILE AND BRITTLE OVERLOAD OF THE MATERIAL AND FRACTURE. NO EVIDENCE WAS FOUND INDICATING PRODUCT ERROR WAS A CONTRIBUTING FACTOR TO THE DEVICE BREAKAGE AND THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. MONITOR COMPLAINTS. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.