MalfunctionKGS
PRELOADED MINI-REVO ANCHR
Received Dec 7, 1998 · Event occurred Nov 4, 1998
Report 1017294-1998-00048 · MDR key 201674
Device
Generic name
Revo
Manufacturer
Linvatec Corp.Model number
M74-139-400Catalog number
C6109A
Lot number
0006639, 0005913
Product problems
- Break
- Design/structure problem
- Difficult to Insert
- Device, or device fragments remain in patient
- Replace
- Tip breakage
- Fitting Problem
Patient
20 YR
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
DURING SHOULDER ARTHROSCOPY PROCEDURE OF THE RIGHT SHOULDER, MINI-REVO SCREW BROKE OFF UPON INSERTION, PROXIMAL TO THE THREAD. THE SURGEON DID NOT REMOVE THE SCREW. A SECOND SCREW WAS INSERTED, DR WAS NOT HAPPY WITH THE DEPTH AND TRIED TO REMOVE IT WHEN IT BROKE. TWO ADDITIONAL SCREWS WERE BROKEN. AS PER USER FACILITY, THEY HAD TROUBLE GETTING SCREWS SEATED IN THE SCREW DRIVER. HE STATED THAT THE INSERTION WAS ROUNDED OFF.