BUDDE HALO RETRACTOR
Received Jun 7, 2018
Report 3004608878-2018-00099 · MDR key 7577933
Device
Product problems
- Material Deformation
- Material Deformation
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED FOR EVALUATION. THE COMPRESSION BALL WAS OVAL ON THE ID PREVENTING SMOOTH MOVEMENT OF THE BAR THROUGH THE BALL. AS PER DHR REVIEW, BUILD RECORDS WERE REVIEWED AND NO ISSUES WERE FOUND. THE REPORTED COMPLAINT HAS BEEN CONFIRMED. ROOT CAUSE: THE SPHERES HAVE BEEN COMPRESSED OUT OF ROUND, EITHER BY TORQUEING THE ITEM DOWN WHILE IT WAS NOT PROPERLY SEATED OR THE BALL HAS BEEN OVER-TORQUED.
Description of Event or Problem
A CUSTOMER REPORTED THAT ON AN UNSPECIFIED DATE, THEY RECEIVED ONE (B)(4) COMPRESSION BALL FROM THE A1040 BUDDE HALO RETRACTOR AND IT WAS NOTED TO BE "ELLIPTICALLY SHAPED NOT ROUND". IT DOES NOT ALLOW THE ROD TO PASS THROUGH AS IT SHOULD. THERE WAS NO PATIENT PREPPED FOR SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.