SPECTRUM C6385Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854018699), received between Dec 22, 2022 and Dec 22, 2022 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryDec 22, 2022Material Fragmentation; Material Fragmentation

  INTERNATIONAL COMPLAINTS REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, C6385, SPECTRUM II SUTURE HOOK, DISPOSABLE, SMALL, WAS BEING USED DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED ¿DURING SURGERY THE TIP OF THE SUTURE HOOK BROKE INSIDE THE PATIENT, AND IT WAS NOT POSSIBLE TO RETRIEVE THE BROKEN PART AS IT WOULD HAVE CAUSED MORE DAMAGE TO THE PATIENT. THE BROKEN TIP REMAINED INSIDE THE PATIENT WHILE CONFIRMATION OF MRI¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE WAS ¿IMPOSSIBLE TO REMOVE¿ AND THE PROCEDURE WAS COMPLETED WITH A 15-MINUTE DELAY. THE PATIENT'S CURRENT STATUS WAS REPORTED AS "GOOD". THERE WAS NO REPORT OF EXTENDED HOSPITALIZATION FOR THE PATIENT THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO RETAINED FOREIGN OBJECT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16033535 ↗