SPECTRUM C6380Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10845854018545), received between May 24, 2017 and Dec 19, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE THAT THE C6380 SPECTRUM II SUTURE HOOK, DISPOSABLE, 45° RIGHT DEVICE WAS BEING USED ON (B)(6) 2025 DURING AN INSTABILITY REPAIR PROCEDURE WHEN IT WAS REPORTED ¿TIP BROKE OFF ON FIRST PASS ATTEMPT THROUGH LABRUM WITH MILD PRESSURE.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT INTO THE SURGICAL SITE AND WAS REMOVED WITH THE USE OF AN ARTHROSCOPIC GRASPER. PROCEDURE WENT WELL WITH A SECOND DEVICE. 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 23854912 ↗
• MalfunctionSep 16, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE C6380 SPECTRUM II SUTURE HOOK, DISPOSABLE, 45° RIGHT DEVICE WAS BEING USED DURING A LABRAL PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED ¿SURGEON WAS USING SPECTRUM WITH THE RIGHT HOOK, HOOK BROKE OFF. SURGEON DID NOT SEEM TO BE FORCING IT THROUGH THE TISSUE. SURGEON REMOVED THE PIECE AND A BLITZ WAS OPENED.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE AND 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 23066103 ↗
• MalfunctionDec 9, 2024Material Fragmentation; Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE C6380, SPECTRUM II SUTURE HOOK, DISPOSABLE, 45° RIGHT DEVICE WAS USED IN A LABRAL REPAIR PROCEDURE ON (B)(6) 2024, AND ¿LABRAL REPAIR USING SPECTRUM2 WITH DISPO HOOKS. THE HOOK BROKE OFF WHEN ATTEMPTING TO PASS SUTURE AROUND BICEP TENDON. NO KNOWN PATIENT IMPACT AT THIS TIME¿. PER FURTHER ASSESSMENT, ALL FRAGMENTS WERE RETRIEVED WITH "LIKELY A GRASPER". THE PROCEDURE WAS COMPLETED AS NORMAL WITH A "REPLACEMENT SPECTRUM HOOK", AND A DELAY OF UNKNOWN DURATION. THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT, WHOSE STATUS IS DESCRIBED AS "FINE". 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 20880671 ↗
• MalfunctionJul 10, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE C6380 SPECTRUM II SUTURE HOOK, DISPOSABLE, 45 DEGREE RIGHT, QTY 5 WAS BEING USED ON (B)(6) 2023 DURING A SHOULDER ARTHROSCOPY PROCEDURE AND ¿THE HOOK BROKE DURING THE OPERATION. ANOTHER HOOK WAS USED TO COMPLETE THE PROCEDURE - DEVICE FULLY RECOVERED.¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER HOOK. PER ASSESSMENT IT WAS FOUND "THE BROKEN END OF THE HOOK COULD BE RECOVERED IN ITS ENTIRETY.¿ 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 17288483 ↗
• MalfunctionMay 24, 2017Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT DURING USE OF THIS SPECTRUM II SUTURE HOOK, 45 DEGREE RIGHT, DISPOSABLE IN AN ARTHROSCOPIC SHOULDER BANKART REPAIR PROCEDURE ON (B)(6) 2017, THE TIP OF THE HOOK BROKE OFF IN THE PATIENT'S SHOULDER AND WAS SUCCESSFULLY REMOVED WITH A GRASPER. THE PROCEDURE WAS OTHERWISE COMPLETED USING ANOTHER SPECTRUM II SUTURE HOOK, 45 DEGREE RIGHT, DISPOSABLE WITH NO FURTHER COMPLICATIONS OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6587378 ↗