DAUTREY ARCH BAR, 15CM
Received Oct 4, 2013 · Event occurred Sep 10, 2013
Report 0008010177-2013-00251 · MDR key 3388261
Device
Generic name
Instrument
Manufacturer
Stryker Leibinger FreiburgCatalog number
01-02960
Lot number
6000008879
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER COMPLAINED THAT THE ARCH BAR HAS EDGES. IT PULLS OR TEARS GUMS. THE RAIL IS VERY EDGY AND IT IS FEARED THAT IT CAN HURT THE PATIENT. THE CUSTOMER HAD TO TOP THE ITEMS OFF, REGRIND THEM AND BEND THEM BEFORE USE WHICH CAUSED A DELAY OF 30 MINUTES.
Additional Manufacturer Narrative
INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.
Additional Manufacturer Narrative
THE REPORTED EVENT COULD BE CONFIRMED. VISUAL INSPECTION REVEALED THAT THE EDGES OF THE CURRENT ARCH BARS ARE VERY SHARP. HOWEVER, WITHIN FUNCTIONAL INSPECTION THE REPORTED EVENT COULD NOT BE REPRODUCED. ALSO A COMPARISON WITH THE CURRENT DRAWING HAS SHOWN THAT THE PRODUCTS MEET THE SPECIFICATION. TO ADDRESS THE CUSTOMER CONCERNS A CHANGE REQUEST WAS INITIATED ON 2014-MAR-10 TO REDESIGN THE ARCH BAR IN A WAY IT GETS SMOOTHER. AS A PART OF THE REDESIGN THE EDGES WILL BE NEW DEFINED (ROUNDED OFF) AND THE PEGS MORE CURVED. THE CHANGE REQUEST IS STILL ONGOING.
Description of Event or Problem
THE CUSTOMER COMPLAINED THAT THE ARCH BAR HAS EDGES. IT PULLS OR TEARS GUMS. THE RAIL IS VERY EDGY AND IT IS FEARED THAT IT CAN HURT THE PATIENT. THE CUSTOMER HAD TO TOP THE ITEMS OFF, REGRIND THEM AND BEND THEM BEFORE USE WHICH CAUSED A DELAY OF 30 MINUTES.