CURVED PELVIC OSTEOTOME 20MM WIDTH
Received Mar 8, 2013 · Event occurred Jan 28, 2013
Report 8030965-2013-00752 · MDR key 2995394
Device
Product problems
- Break
- Entrapment of Device
Patient
25 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING PERI OSTEOTOMY OPERATION ON (B)(6) 2013, THE CHISEL BROKE OFF AT THE HANDLE AND DISCONNECTED FROM THE REST OF THE CHISEL. THE CHISEL WAS STUCK IN THE BONE AND THEY HAD TO USE ANOTHER DEVICE TO GET IT OUT. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED. SURGERY PROLONGED APPROXIMATELY 10 TO 15 MINUTES. SALES CONSULTANT WAS NOT IN THE OR AND WAS TOLD BY THE COORDINATOR.
Additional Manufacturer Narrative
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. PLACEHOLDER.