SPECTRUM C6362Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10845854013007), received between Jul 19, 2018 and Jun 16, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2025Material Fragmentation; Material Fragmentation

  A CUSTOMER REPORTED THAT THE C6362, SPECTRUM II SUTURE HOOK, 60° RIGHT DEVICE WAS USED IN AN UNNAMED PROCEDURE ON (B)(6) 2025, AND "STERILIZED SPECTRUM HOOK 2 TIMES AND NOT YET USED; THE HOOK TIP HAS BROKEN IN THE PATIENT¿S SHOULDER; WE RECOVERED THE TIP; NEW EQUIPMENT THAT SHOULD NOT BE BROKEN AT THE FIRST USE¿. THE PROCEDURE WAS COMPLETED, AND 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22210305 ↗
• MalfunctionOct 14, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, C6362, SPECTRUM II SUTURE HOOK, 60° 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 20438243 ↗
• MalfunctionSep 27, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE C6362 SPECTRUM II SUTURE HOOK, 60 DEGREE RIGHT, DEVICE BROKE DURING A SHOULDER LEFT ARTHROSCOPY ON (B)(6) 2018. THIS CAUSED A 5-MINUTE DELAY IN THE PROCEDURE WHILE THE BROKEN COMPONENT WAS REMOVED FROM THE PATIENT USING SURGICAL PLIERS. THERE WAS NO REPORT OF PATIENT INJURY DURING THIS EVENT. 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 7913831 ↗
• MalfunctionJul 19, 2018Fracture; Fracture

  THIS DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE C6362, SPECTRUM II SUTURE HOOK, 60 DEGREE RIGHT, DEVICE BROKE DURING A ROTATOR CUFF REPAIR PROCEDURE WHILE THE SURGEON WAS TRYING TO PASS THE SUTURE INSIDE THE ROTATOR CUFF. THE EVENT CAUSED A 30-MINUTE DELAY IN THE PROCEDURE. THE BROKEN COMPONENT WAS RETRIEVED FROM THE PATIENT USING A GRASPER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A STRAIGHT SUTURE PASSER. THERE WAS NO REPORT OF INJURY TO USER OR PATIENT DURING THIS EVENT. 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 7704291 ↗