RSP 4.0MM TAPERED TIP 6BOX ST
Received Jun 1, 2026 · Event occurred Apr 23, 2026
Report 0002242056-2026-00007 · MDR key 25354456
Device
Product problems
- Physical Resistance/Sticking
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING CREATION OF A HOLE TO ATTACH THE LIMA TO A TUBE GRAFT, THE DEVICE CONTINUED TO CATCH AND LOCK, AND A SECOND PRODUCT WAS OPENED TO PROCEED. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY AS A RESULT OF THE EVENT. FURTHER, IT IS UNKNOWN IF THERE WAS A DELAY IN PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN: EVENT OCCURRED IN CANADA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.