MalfunctionHTT
*
Received Mar 1, 2013 · Event occurred Feb 21, 2013
Report 3003752 · MDR key 3003752
Device
Generic name
Burr, Orthopedic, Arthoscopy
Manufacturer
Linvatec CorporationModel number
H9102Catalog number
H9102
Lot number
410057
Product problems
- Metal Shedding Debris
Patient
70 YR
- No Information
Narrative
Description of Event or Problem
AS THE PHYSICIAN USED THE LINVATEC DISPOSABLE BUR, METAL SHAVINGS WERE WITNESSED FROM THE THE BUR INSIDE THE SHOULDER JOINT. THE PHYSICIAN STOPPED USING AND THOROUGHLY WASHED OUT THE SHOULDER.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SHOULDER ARTHROSCOPY.