MalfunctionOVN
DEK BL MF 0 TC-43/HR 26 2N 36"
Received Jan 30, 2018 · Event occurred May 23, 2017
Report 3004365956-2018-00030 · MDR key 7228810
Device
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE HISTORY RECORD OF BATCH NUMBER PROVIDED HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
Description of Event or Problem
IT WAS REPORTED THAT THE TIP OF THE SUTURE THAT WAS CONNECTED TO THE DEVICE BROKE DURING THE CASE. IT WAS EMBEDDED TO THE PATIENT'S LIGAMENT.