MalfunctionILZ
DYNA MED
Received Jun 21, 2010 · Event occurred Jun 1, 2010
Report MW5016435 · MDR key 1732882
Device
Generic name
Traction Splint
Product problems
- Out-Of-Box Failure
- Defective Device
- Device Operates Differently Than Expected
- Manufacturing, Packaging or Shipping Problem
Patient
50 YR
- No Information
Narrative
Description of Event or Problem
DESIGN OF PRODUCT CHANGED A FEW YEARS AGO. PRODUCT IS ENGINEERED POORLY. ORDER FOR 7 PLACED, ON ARRIVAL 4 WERE OUT OF BOX DEFECTIVE. COMPANY REPLACED 4 AND UPON DELIVERY 3 WERE OUT OF BOX FAILURES. LOCKING MECHANISM FAILURES AND KICKSTAND AND MECHANICAL TRACTION. RED CLIPS FAIL CONSTANTLY.