Triathlon 5546-A-402Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327026214), received between Mar 22, 2018 and Mar 22, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AFTER OPENING THE UNDAMAGED IMPLANT PLASTIC AND CARDBOARD BOX THE SCOUT NOTICED THE TOP LAYER OF PAPER ON THE FIRST STERILE PLASTIC CONTAINER WAS PERFORATED, THE NEXT LAYER WAS ALSO PERFORATED AND HENCE THE IMPLANT WAS DEEMED UNSTERILE AND NOT USED. THERE WERE NO ADVERSE CONSEQUENCES AS THERE WAS AN IDENTICAL IMPLANT ON THE LOAN SET.

  Patient problems: No Patient Involvement

  MAUDE report 7363265 ↗