MalfunctionKGS
ACUFEX TAG ROD II, STERILE BOX 1, PKG 1
Received Jul 23, 1998 · Event occurred Jun 22, 1998
Report 1219602-1998-00033 · MDR key 178825
Device
Generic name
Suture Retention Device
Manufacturer
Smith & Nephew, Inc. Endoscopy DivisionModel number
NACatalog number
014349
Lot number
004491
Product problems
- Break
- Difficult to Insert
Patient
UNKNOWN
- No Consequences Or Impact To Patient
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
TAG SUTURE ANCHOR REPORTED TO HAVE BROKEN UPON INSERTION. BROKEN PIECE WAS RETRIEVED WITHOUT DELAY OR INJURY TO THE PATIENT.