SPECTRUM C6381Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10845854019863), received between Feb 27, 2019 and Dec 14, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE C6381, SPECTRUM II SUTURE HOOK, DISPOSABLE, 45 DEGREE LEFT, DEVICE WAS BEING USED DURING A SHOULDER ARTHROSCOPY PROCEDURE ON 23OCT23 WHEN IT WAS REPORTED ¿DURING SHOULDER ARTHROSCOPIC SURGERY, THE SPECTRUM HOOK BROKE INTO TWO PARTS AT THE TUBE/HOOK JUNCTION. IT FELL INTO THE PATIENT'S SHOULDER. THE SURGEON REMOVED THE PIECE WITH IMPORTANT DIFFICULTY GIVEN THE SMALL SIZE OF THE DEVICE.¿. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR EXTENDED HOSPITALIZATION FOR THE PATIENT. 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 18324213 ↗
• MalfunctionJan 29, 2020Material Fragmentation; Material Fragmentation

  THIS DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE C6381 DEVICE WAS BEING USED DURING A BANKART PROCEDURE ON (B)(6) 2020 WHEN THE DEVICE TIP BROKE IN THE PATIENT. IT WAS REPORTED THAT ALL PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE AFTER A 2-MINUTE DELAY. 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 9642224 ↗
• MalfunctionFeb 27, 2019Break; Dull, Blunt; Break; Dull, Blunt

  THE CUSTOMER REPORTED AN ISSUE WITH THE SPECTRUM II SUTURE HOOK, DISPOSABLE, 45 DEGREE LEFT, ITEM # C6381, LOT 966582, THAT OCCURRED ON (B)(6) 2019 DURING USE IN A SHOULDER STABILIZATION PROCEDURE. IT WAS REPORTED THAT THE C6381 SUTURE HOOK BROKE OFF IN A PATIENT'S SHOULDER. THE HOOK WAS RETRIEVED. IT IS INDICATED THAT THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A REPORTED 20-MINUTE DELAY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPORTER AND THE HOSPITAL ON (B)(6) 2019. THE ARTHROSCOPIC BANKART PROCEDURE WAS APPROXIMATELY MIDWAY THROUGH, HAVING MOBILIZED THE TISSUE AND PREPARED THE BONE SURFACE. THE DOCTOR WAS HANDED THE LIMITED USE SUTURE HOOK FOR THE FIRST ATTEMPT AT PASSING THE SUTURE THROUGH TISSUE. THIS HOOK WAS BLUNT, THEREFORE SHE WAS OFFERED THE SINGLE USE SUTURE HOOK, WHICH SHE ACCEPTED AND ATTEMPTED TO USE TO PASS THROUGH THE SAME TISSUE AS THE FIRST ATTEMPT. THIS HOOK WAS REMOVED FROM THE PACKAGING JUST PRIOR TO THIS AND WAS PREVIOUSLY UNUSED. THE DOCTOR FOUND THAT THIS WAS ALSO BLUNT, AND THAT IS WHEN THE SUTURE HOOK BROKE OFF. IT TOOK APPROXIMATELY 20-MINS TO RETRIEVE THE BROKEN PART WHICH WAS RETRIEVED WHOLE. NO FRA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8375605 ↗