SPECTRUM C6369Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854031100), received between Sep 25, 2025 and Sep 25, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 25, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, C6369, SPECTRUM II SUTURE HOOK, SMALL CRESCENT WAS BEING USED ON (B)(6) 2025 DURING A KNEE ARTHROSCOPY FOR MENISCUS SUTURE AND "USE OF THE SPECTRUM HOOK (CONMED). 4TH USE (PREVIOUSLY ON (B)(6) 2025; (B)(6) 2025; (B)(6) 2025). THE RIGHT HOOK BROKE INSIDE THE JOINT DURING THE PROCEDURE WITHOUT THE SURGEON FORCING IT. THE PIECE OF METAL WAS RECOVERED AND DID NOT REMAIN IN THE PATIENT'S KNEE.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23141970 ↗