SPECTRUM C6382Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10845854018675), received between Feb 23, 2023 and Jul 22, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE C6382 SPECTRUM II SUTURE HOOK, DISPOSABLE, 60° RIGHT DEVICE WAS BEING USED DURING AN UNKNOWN PROCEDURE ON APPROXIMATELY (B)(6) 2025 WHEN IT WAS REPORTED ¿THE HOOK PART BROKE LOOSE FROM THE SHAFT OF THE PRODUCT, THIS HAPPENED INSIDE THE PATIENT'S SHOULDER JOINT BUT COULD BE MANUALLY RECOVERED.¿ THERE WAS NO REPORT PF INJURY, MEDICAL OR SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR 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 22564093 ↗
• MalfunctionFeb 23, 2023Material Fragmentation; Material Fragmentation

  INTERNATIONAL COMPLAINTS REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE C6382, SPECTRUM II, SUTURE HOOK, DISPOSABLE, 60 DEGREE RIGHT, WAS BEING USED ON (B)(6) 2023 DURING A LABRAL REPAIR PROCEDURE WHEN IT WAS REPORTED ¿SURGEON INSERTED SPECTRUM HOOK INTO LABRUM ARTHROSCOPICALLY. END OF HOOK BROKE OFF INSIDE JOINT. RETRIEVED IMMEDIATELY." IT WAS ALSO REPORTED THAT THERE WERE NO CHANGES TO THE PROCEDURE. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE FRAGMENT WAS REMOVED USING A GRASPER. THE PROCEDURE WAS COMPLETED WITH A 2-MINUTE DELAY AND THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿NO EFFECT.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16431555 ↗