MalfunctionLXH
SCOVILLE HEMILAMINECTOMY RETRACTOR FRAME, SPRE
Received Jul 26, 2007
Report 2430952-2007-00019 · MDR key 888824
Device
Generic name
Surgical Instruments
Manufacturer
Rudolf Storz GmbhModel number
*Catalog number
290-210
Lot number
*
Product problems
- Break
- Difficult to Insert
- Replace
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THE DEVICE BROKE WHEN TIGHTENING THE WING NUT DURING A SURGICAL PROCEDURE. THE NUT CAME APART FROM THE SHAFT (WELDED JOINT SEEMED TOO WEAK). THE SURGICAL PROCEDURE HAD TO BE FINISHED USING ANOTHER DEVICE. NO PATIENT INJURY IS REPORTED.