TRIAL SPACER HANDLE
Received Feb 2, 2016 · Event occurred Jan 15, 2016
Report 3003875359-2016-10067 · MDR key 5404280
Device
Product problems
- Break
- Break
Patient
49 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION / INVESTIGATION, BUT HAS YET TO BE RECEIVED.DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: 04. APR. 2014, NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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
IT WAS REPORTED THE SURGEON WAS PERFORMING AN ANTERIOR LUMBAR INTERBODY FUSION AT L4-S1 WHEN THE TRIAL HANDLE/SPINDLE BROKE. WHILE USING THE FRA SPACER SYSTEM, THE TRIAL HANDLE/SPINDLE BROKE INSIDE THE TRIAL AND THE TRIAL WAS STUCK INSIDE THE DISC SPACE. THE TRIAL WAS REMOVED WITH KOCHER AND SURGEON HAD TO DRILL THE BONE SLIGHTLY. THERE WAS A 5 MINUTE SURGICAL DELAY AND NO HARM TO THE PATIENT. THIS IS 1 OF 1 FOR (B)(4).