SPECTRUM C6370Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10845854031117), received between Dec 14, 2017 and Dec 17, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, C6370 SPECTRUM II SUTURE HOOK, MEDIUM CRESCENT WAS BEING USED ON (B)(6) 2025 AND "DURING AN ARTHROSCOPIC LABRAUM REPAIR PROCEDURE, THE DISTAL TIP OF THE SUTURE HOOK INSTRUMENT FRACTURED WHILE PASSING THROUGH THE TISSUE, WITHOUT CONTACT WITH BONE STRUCTURES.¿ PER FURTHER ASSESSMENT IT WAS REPORTED THAT "ACCORDING TO THE SURGEON¿S REPORT, ONLY A COMPONENT OF THE DEVICE ¿THE DISTAL TIP OF THE SUTURE HOOK ¿ DETACHED DURING PASSAGE THROUGH THE LABRAL TISSUE, WITHOUT CONTACTING ANY BONE STRUCTURES. THE FRAGMENT FELL INTO THE SURGICAL SITE BUT WAS IMMEDIATELY VISUALIZED AND RETRIEVED WITHOUT COMPLICATION, AFTER WHICH THE INSTRUMENT WAS REPLACED TO CONTINUE THE PROCEDURE." THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED. WITH REPLACEMENT OF THE DISTAL PASSER TIP (INTEGRATED NEEDLE), WITHOUT FURTHER INCIDENT¿. 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 23828590 ↗
• MalfunctionOct 8, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE C6370, SPECTRUM II SUTURE HOOK, MEDIUM CRESCENT WAS BEING USED ON (B)(6) 2024 DURING A ROTATOR CUFF REPAIR PROCEDURE WHEN IT WAS REPORTED ¿MEDIUM SUTURE HOOK BROKE YESTERDAY IN A PATIENT'S SHOULDER.¿. FURTHER ASSESSMENT FOUND THAT ¿A GRAPSER WAS USED TO RETRIEVE THE NEEDLE.¿. THE PROCEDURE WAS COMPLETED AND ¿THE DEVICE BREAKING DID NOT CAUSE INJURY TO PATIENT. CURRENT STATUS IS UNKNOWN.¿ 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 20396232 ↗
• MalfunctionDec 14, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE C6370, SPECTRUM II SUTURE HOOK, MEDIUM CRESCENTWAS BEING USED ON AN UNKNOWN DATE WHEN IT WAS REPORTED ¿THE NEEDLE BROKE WHILE IT WAS BEING USED, RELEASING A FRAGMENT INTO THE PATIENT.¿ WE WERE INFORMED THAT THE SURGEON CORRECTED THE PROCEDURE WITHOUT MAJOR HARM TO THE PATIENT. UNTIL NOW WE DON¿T KNOW IF ANOTHER PRODUCT WAS USED TO REPLACE IT, AND IF THE TIME OF SURGERY TIME WAS AFFECTED.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿THE TIP OF THE INSTRUMENT BROKE INSIDE THE PATIENT'S JOINT. IT WAS RECOVERED. THE BROKEN TIP WAS REMOVED WITH GRASPER FORCEPS".¿ THE PROCEDURE WAS COMPLETED, AND THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿HE IS WELL. RECOVERING FROM THE PROCEDURE.¿. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325408 ↗
• MalfunctionFeb 9, 2023Material Fragmentation; Material Fragmentation

  THE CONMED CANADA REPORTED ON BEHALF OF THE CUSTOMER THAT THE C6370, SPECTRUM II SUTURE HOOK, MEDIUM CRESCENT WAS BEING USED DURING AN INSTABILITY PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿HOOK BROKE OFF IN SHOULDER.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE WAS RETRIEVED USING ¿GENERAL SURGERY STYLE MANUAL INSTRUMENT.¿ THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATIVE ARTHREX FIRESTICK DEVICE AND OVER 30 MINUTE DELAY WAS REPORTED. IT WAS ALSO REPORTED THAT ¿THERE IS NO CONCERNS FOR THE PATIENT¿S STATUS AS THE SURGERY WENT AS PLANNED.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION REQUIRED 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 16337130 ↗
• MalfunctionDec 14, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, C6370 SPECTRUM II SUTURE HOOK, MEDIUM CRESCENT WAS BEING USED ON APPROXIMATELY ON (B)(6) 2022 AND ¿THE CRESCENT BROKE OFF IN THE ROTATOR CUFF. X-RAY WAS CALLED IN AN THE TIP WAS RETRIEVED FROM THE PATIENT. 10 MINUTE DELAY IN THE CASE. NO HARM TO THE PATIENT.¿ THERE WAS NO IMPACT OR INJURY TO 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 15975893 ↗
• MalfunctionOct 11, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE C6370, SPECTRUM II SUTURE HOOK, MEDIUM CRESCENT WAS BEING USED ON 03OCT22 DURING A LABRAL REPAIR PROCEDURE WHEN IT WAS REPORTED ¿AFTER ONE USE THE HOOK SEPARATED FROM THE POST IN THE SHOULDER.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿THE DEVICE DID FRAGMENT AND WAS RETRIEVED USING A KING FISCHER INSTRUMENT¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DISPOSABLE HOOK AND A 2-MINUTE DELAY WAS REPORTED DURING THE PROCEDURE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR HOSPITALIZATION REQUIRED FOR THE PATIENT. THE CURRENT STATUS OF THE PATIENT IS ¿GOOD¿. 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 15578988 ↗
• MalfunctionMar 27, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED BY THE SALES REPRESENTATIVE ON BEHALF OF THE FACILITY THAT DURING A SURGICAL EVENT ON (B)(6) 2018 THE C6370, SPECTRUM II SUTURE HOOK, MEDIUM CRESCENT, BROKE WHILE INSIDE THE CANNULA. NONE OF THE DEVICE COMPONENTS FELL INTO THE SURGICAL SITE AND NO MEDICAL INTERVENTION WAS REQUIRED FOR THE PATIENT. THE DEVICE WAS THEN THROWN AWAY AFTER REMOVAL FROM THE CANNULA. THERE WAS NO DELAY OR CANCELLATION OF THE SURGERY. THIS REPORT IS RAISED ON THE BASIS OF DEVICE MALFUNCTION WITH A POTENTIAL FOR INJURY WITH OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7374806 ↗
• MalfunctionDec 14, 2017Break; Break

  THE CUSTOMER REPORTED WHILE USING A SPECTRUM SUTURE HOOK, THE HOOK BROKE IN THE PATIENTS JOINT. THE BROKEN PIECE WAS NOT DETACHED UNTIL IT WAS FULLY REMOVED FROM THE PATIENT. ALL PIECES/FRAGMENTS HAVE BEEN RETRIEVED. THE PROCEDURE WAS COMPLETED AS INTENDED WITH THE USE OF AN ALTERNATIVE DEVICE. NO PATIENT INJURY WAS REPORTED. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7118611 ↗
• MalfunctionDec 14, 2017Break; Break

  THE CUSTOMER REPORTED WHILE USING A SPECTRUM SUTURE HOOK, THE HOOK BROKE INSIDE THE CANNULA. THE BROKEN PIECE WAS RETRIEVED FROM THE CANNULA AND THIS MALFUNCTION CAUSED A 2 MINUTE SURGICAL DELAY. THE PROCEDURE WAS COMPLETED AS INTENDED WITH THE USE OF AN ALTERNATIVE DEVICE. NO PATIENT INJURY WAS REPORTED. THIS REPORT IS RAISED ON THE BASIS OF A REPORTED DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7118607 ↗