inforMED
MalfunctionFSM

PANGEA TRAY SYSTEM

Received Jul 21, 2026

Report MW5190929 · MDR key 25893207

Device

Generic name

Tray, Surgical, Instrument

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE STRYKER PANGEA TRAY SYSTEM FOR ORTHO TRAUMA PROCEDURES WAS PUT INTO CIRCULATION AFTER COMMISSIONING INTO OUR SYSTEM. WE DISCOVERED THAT THE LETTERING AND SILHOUETTES OF INSTRUMENTS IDENTIFYING WHAT THE INSTRUMENT IS AND WHERE IN THE TRAY THEY BELONG WAS PEELING AFTER THE FIRST WASH. THIS WAS REPORTED TO OUR LOCAL REP FROM STRYKER WHO STATED THIS WAS A KNOWN ISSUE, AND IT WAS DETERMINED THAT REQUESTING REPLACEMENTS WILL RESULT IN A SIMILAR OUTCOME. WITH THE PEELING OF THE LETTERING, SILHOUETTES, ETC. BEING A KNOWN ISSUE, WHY CONTINUE TO HAVE THIS AS PART OF THE MANUFACTURING PROCESS OF THE TRAYS?