SPECTRUM C6360Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10845854018385), received between Jul 2, 2018 and Oct 14, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 14, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, C6360, SPECTRUM II SUTURE HOOK, 45° RIGHT, WAS BEING USED DURING A BANKART REPAIR PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿TIP BROKE DURING THE SURGERY.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT FOUND THAT THE TIP HAD FALLEN INTO THE PATIENT AND WAS RETRIEVED WITH A GRASPER. THE PROCEDURE WAS COMPLETED AS PLANNED WITH A 5-MINUTE DELAY. 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 20438242 ↗
• MalfunctionSep 30, 2024Material Fragmentation; Material Fragmentation

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE C6360, SPECTRUM II SUTURE HOOK, 45° RIGHT DEVICE WAS BEING USED DURING A SHOULDER ROTATOR CUFF PROCEDURE ON (B)(6) 2024, AND "DURING THE OPERATION, WHILE THE SURGEON WAS USING THE INSTRUMENT, THE HOOK GOT BROKEN FROM THE HOOK SIDE BROKEN PIECE HAS BEEN RETRIEVED FROM PATIENT WITH NO HARM.". THE PROCEDURE WAS COMPLETED WITH A DELAY OF 10-15 MINUTES. THERE WAS 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. THE C6362, SPECTRUM II SUTURE HOOK, 60° RIGHT WILL BE LISTED AS A CONCOMITANT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333431 ↗
• MalfunctionSep 30, 2024Material Fragmentation; Material Fragmentation

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE C6360, SPECTRUM II SUTURE HOOK, 45° RIGHT DEVICE WAS BEING USED DURING A SHOULDER ROTATOR CUFF PROCEDURE ON (B)(6) 2024, AND "DURING THE OPERATION, WHILE THE SURGEON WAS USING THE INSTRUMENT, THE HOOK GOT BROKEN FROM THE HOOK SIDE BROKEN PIECE HAS BEEN RETRIEVED FROM PATIENT WITH NO HARM.". THE PROCEDURE WAS COMPLETED WITH A DELAY OF 10-15 MINUTES. THERE WAS 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. THE C6362, SPECTRUM II SUTURE HOOK, 60° RIGHT WILL BE LISTED AS A CONCOMITANT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333429 ↗
• InjuryFeb 9, 2024Material Fragmentation; Material Twisted/Bent; Material Fragmentation; Material Twisted/Bent

  A CUSTOMER REPORTED THAT THE C6380, SPECTRUM II SUTURE HOOK, DISPOSABLE, 45 DEGREE RIGHT, QTY 5 DEVICE WAS BEING USED DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2024, AND ¿HOOK BROKEN DURING INTERVENTION¿. PER FOLLOW-UP ASSESSMENT, "THE HOOK WAS IN THE TENDON WHEN THE END FRAGMENTED" AND THE FRAGMENT WAS RECOVERED. "AN ADDITIONAL INCISION WAS MADE TO SUCCESSFULLY REMOVE IT". THE PROCEDURE WAS COMPLETED WITH A DELAY OF "UNKNOWN BUT REASONABLE" DURATION. THERE WAS NO REPORT OF FURTHER MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF ADDITIONAL INCISION TO THE PATIENT. ADDITIONAL INFORMATION: IT WAS DISCOVERED DURING EVALUATION THAT COMPLAINT INVOLVED THE C6360, SPECTRUM II SUTURE HOOK, 45 DEGREE RIGHT DEVICE, AND NOT THE C6380, SPECTRUM II SUTURE HOOK, DISPOSABLE, 45 DEGREE RIGHT, QTY 5 DEVICE, AS INITIALLY REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 18675828 ↗
• InjuryMay 19, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE C6360, SPECTRUM II SUTURE HOOK, 45 DEGREE RIGHT, WAS BEING USED ON (B)(6) 2023 DURING A SHOULDER INSTABILITY PROCEDURE WHEN IT WAS REPORTED ¿SPECTRUM HOOK RIGHT 45 DEGREE BROKE WHEN PASSING THE TISSUE. TRY TO TAKE IT OUT, BUT THE PIECE BROKE WHEN TO ANTERO INFERIOR AXILLARY POUCH. SO COULDN¿T TAKE IT OUT.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE AND A 1-HOUR DELAY WAS REPORTED. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR HOSPITALIZATION REQUIRED FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO PATIENT RETAINING A FOREIGN OBJECT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16960349 ↗
• MalfunctionMar 14, 2023Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE C6360, SPECTRUM II SUTURE HOOK, 45 DEGREE RIGHT, WAS BEING USED DURING A SHOULDER SCOPE PROCEDURE ON THE DATE OF 12FEB23, WHEN IT WAS REPORTED, ¿INSTRUMENT BROKE DURING SURGERY. (THE INSTRUMENT HAD FRAGMENTED)¿. AFTER FURTHER ASSESSMENT, IT WAS REPORTED, THE DEVICE DID FRAGMENT INTO THE SURGICAL SITE, BUT IT WAS RETRIEVED WITH A FORCEP INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO REPORT OF PATIENT OR USER INJURY, PROLONGED HOSPITALIZATION, OR MEDICAL INTERVENTION. 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 16542243 ↗
• MalfunctionMar 3, 2023Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE C6360, SPECTRUM II SUTURE HOOK, 45 DEGREE RIGHT, WAS BEING USED DURING A SHOULDER SCOPE PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿BROKEN DURING SURGERY.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED DELAY. FURTHER ASSESSMENT REQUEST FOUND THAT DEVICE FRAGMENTED DURING THE PROCEDURE, WHEN APPLYING FORCE TO CUT THROUGH THE TISSUE AND THE FRAGMENT WAS REMOVED USING FORCEPS. 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 16477034 ↗
• MalfunctionJul 2, 2018Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE C6360, SPECTRUM II SUTURE HOOK, 45 DEGREE RIGHT, BROKE AT THE TIP WHILE PASSING SUTURES DURING A ROTATOR CUFF REPAIR ON (B)(6) 2018. THE COMPONENT WAS REMOVED USING GRASPERS WHICH CAUSED A 2-MINUTE DELAY IN PROCEDURE. THERE WAS NO MEDICAL INTERVENTION OR EXTENDED STAY IN THE HOSPITAL FOR THE PATIENT. THE PATIENT IS REPORTED IN GOOD STATUS AND WENT HOME THE SAME DAY OF THE PROCEDURE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7654792 ↗