Spectrum C6361Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10845854018668), received between Dec 8, 2022 and Aug 1, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, C6361, SPECTRUM II SUTURE HOOK, 45° LEFT, WAS BEING USED DURING A MENISCAL REPAIR PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿DURING THE OPERATION, THE SURGEON TRIED TO USE THE HOOK FOR PASSING THE SUTURE. BUT WHEN HE USED THE HOOK TO PIERCE THROUGH THE MENISCUS AND THE TIP OF HOOK WAS BROKEN.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT QUESTIONING OF THE REPORTER FOUND THAT ¿THE BROKEN FRAGMENT HAD FALLEN INTO THE SURGICAL SITE. THE FRAGMENT WAS RETRIEVED FROM SURGICAL SITE. SURGEON USED STRAIGHT ARTERY FORCEPS TO REMOVE THE FRAGMENT." AND THE PATIENT WAS "DISCHARGED FROM HOSPITAL.¿ 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 22685291 ↗
• MalfunctionDec 19, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE C6361 SPECTRUM II SUTURE HOOK, 45° LEFT WAS BEING USED ON 05DEC24 DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED ¿BROKE DURING A CASE THIS WEEK. THE HOOK BROKE OFF INSIDE OF THE PATIENT. IT LOOKS LIKE THE HOOK WAS STERILIZED 4 TIMES. NO INJURY. THEY WERE ABLE TO REMOVE FROM PATIENT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL 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 20977528 ↗
• MalfunctionFeb 16, 2024Material Fragmentation; Material Twisted/Bent; Material Fragmentation; Material Twisted/Bent

  A CUSTOMER REPORTED THAT THE C6361, SPECTRUM II SUTURE HOOK, 45 DEGREE LEFT DEVICE WAS BEING USED DURING A SHOULDER ARTHROSCOPY PROCEDURE ON AN UNKNOWN DATE, AND ¿THE HOOK BROKE OFF IN THE PATIENT'S TENDON. THE SURGEON WAS ABLE TO REMOVE THE PIECE OF HOOK WITHOUT CAUSING ANY DAMAGE. THE INCIDENT LENGTHENED THE OPERATING TIME (DURATION UNKNOWN) AND ADDED STRESS FOR THE SURGEON¿. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED 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 18719749 ↗
• MalfunctionDec 8, 2022Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, C6361 SPECTRUM II SUTURE HOOK, 45 DEGREE LEFT WAS BEING USED ON (B)(6) 2022 AND ¿THE DEVICE BROKE DURING SURGERY.¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THERE WAS NO REPORT OF MEDICAL/SURGICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE AND THERE WAS NO DELAY TO THE PROCEDURE. AFTER FURTHER ASSESSMENT IT WAS FOUND THE DEVICE DID FRAGMENT AND FALL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED WITH A GRASPER. 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 15940182 ↗