MalfunctionKGS

PRELOADED MINI-REVO ANCHR

Received Dec 24, 1998 · Event occurred Nov 8, 1998

Report 1017294-1998-00053 · MDR key 204299

Device

Generic name

Revo

Manufacturer

Linvatec Corp.

Model number

M74-139-400

Catalog number

C6109A

Lot number

7628

Product problems

Break
Replace

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

ANCHORS WERE BROKEN DURING BANKART REPAIR SURGERY. THE NECK CONNECTING THE HEX MALE HEAD AND THE SCREW OF THE ANCHOR WAS BROKEN DURING INSERTION. AN ADD'L ANCHOR WAS USED TO REPAIR THE TORN LABRUM. THE SURGERY WAS SATISFACTORY IN THE LABRUM REPAIR.