MalfunctionHSH
NEXGEN MIS INSTRUMENT TRAY
Received May 2, 2012 · Event occurred Feb 4, 2012
Report 1822565-2012-00960 · MDR key 2564224
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Product code (HSH)
Manufacturer (Zimmer, Inc.)
Model (00596700700)
Device
Product problems
- Device Markings/Labelling Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT IS REPORTED THAT THE TRAYS FOR THE NEXGEN SYSTEM CHANGED COLOR EXTREMELY WITHIN A FEW WEEKS. SOME EVEN SHOW BLACK DEPOSITS ON THE SURFACE. THE CLINIC DECIDED NOT TO USE THE TRAYS ANY LONGER DUE TO HYGIENIC REASONS.
Additional Manufacturer Narrative
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.