Triathlon 5545-A-302Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327026399), received between Nov 19, 2019 and Nov 19, 2019 — 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.

• MalfunctionNov 19, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THIS PI IS FOR THE INTRA-OP EVENT. DURING A REVISION OF THE PATIENT'S LEFT KNEE, THE TYVEK OF THE OUTER AND INNER BLISTERS EACH HAD A HOLE IN THEM. NO HOLE IS VISIBLE ON THE OUTER BOX. THE SHRINK RAP WAS TORN AND DISCARDED BEFORE DISCOVERY, THERE IS NO WAY TO DETERMINE IF THERE WAS A HOLE IN THE SHRINK WRAP. DUE TO STERILITY CONCERNS THE DEVICE WAS NOT IMPLANTED. THE REP OPENED BOTH THE OUTER AND INNER STERILE BLISTERS. ANOTHER DEVICE WAS OBTAINED TO COMPLETE THE SURGERY SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY 5 MINUTES WHILE A TOURNIQUET WAS IN USE. THE DEVICE AND PACKAGING (EXCEPT SHRINK WRAP) ARE AVAILABLE FOR RETURN. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9340691 ↗