HI-LINE XXS DIAM. NEURO CUTTER III D3.OMM
Received Jul 30, 2015 · Event occurred Jun 29, 2015
Report 2916714-2015-00641 · MDR key 4963932
Device
Generic name
Burr
Manufacturer
Aesculap, Inc.Model number
GE843SUCatalog number
GE843SU
Lot number
52015288
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: THE BURR WAS INVESTIGATED AND IT WAS DETECTED THAT THE BURR HEAD WAS BROKEN OFF. THE BREAKAGE IS LOCATED APPROXIMATELY 13 MILLIMETERS FROM THE BURR HEAD TO THE MIDDLE OF THE PRODUCT. THE BREAKAGE SURFACE WAS CHECKED AND FOLLOWS THE PATTERN OF A FORCED FRACTURE, VERY LIKELY CAUSED BY HIGH LATERAL FORCES APPLIED TO THE TOOL. THIS CORRESPONDS TO THE FINDINGS OF THE HANDPIECE GB794R (BELOW). INDICATIONS OF A MATERIAL OR MANUFACTURING DEFECT WERE NOT FOUND. ADDITIONAL COMPONENTS : GD675: FUNCTIONS AS INTENDED. GB790R: FUNCTIONS AS INTENDED. GB793R: FUNCTIONS AS INTENDED; HOWEVER, SHOWS SIGNS OF NORMAL WEAR FROM USE. GB794R: FOUND TO BE DAMAGED; SOME PARTS MISSING FROM THE TIP.
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem
TIP BROKE DURING SURGERY. NO PATIENT INJURY OR SURGICAL DELAYS. ADD'L COMPONENTS IN USE: GB790R/HI-LINE XXS HANDPIECE. GD675/MICROSPEED UNI XS HIGHSPEED MOTOR (S/N (B)(4)). GB794R/HI-LINE XXS HANDPIECE SHAFT CURVED III (S/N (B)(4)).