MalfunctionKGS
PRELOADED MINI-REVO ANCHR
Received Dec 4, 1998 · Event occurred Sep 28, 1998
Report 1017294-1998-00047 · MDR key 200896
Device
Generic name
Revo
Manufacturer
Linvatec CorporationModel number
M74-139-400Catalog number
C6109A
Lot number
00007107
Product problems
- Bent
- Break
- Replace
- Tip breakage
Patient
19 YR
- No Consequences Or Impact To Patient
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
PT SCHEDULED FOR RIGHT SHOULDER ARTHROSCOPY AND REPAIR. THE MINI-REVO USED IN THIS PROCEDURE BROKE OFF AT THE EYELET PORTION. A SECOND MINI-REVO BROKE AND THIRD BENT DURING THIS PROCEDURE.