Arthrex® AR-2324KBCCTTRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867351134), received between Sep 17, 2020 and Aug 24, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2023Break; Break

  ON 7/28/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT ONE OF THE SWIVELOCK FROM (2) AR-2600SBS-4 SPEEDBRIDGE IMPLANT SYSTEM FAILED WHILE PRELOADING THE SUTURES. THE SWIVELOCK EYELETS BROKE AWAY FROM THE RETENTION SUTURE WHEN IT WAS BEING INSERTED IN THE CANNULA FOR IMPLANTATION. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING AN AR-2324BCC BIOCOMPOSITE SWIVELOCK. ADDITIONAL INFORMATION RECEIVED ON 8/1/2023: EYELET BROKE WHILE GOING THROUGH THE CANNULA, BUT NEVER MADE IT TO THE PATIENT'S BONE. IT WAS BEING HELD WITH THE SUTURES FROM THE SWIVELOCK AND IT WAS NEVER LOOSE.

  Patient problems: Insufficient Information

  MAUDE report 17610364 ↗
• MalfunctionJun 22, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE EYELET OF AN AR-2324KBCCTT BIOCOMPOSITE KNOTLESS SWIVELOCK BROKE WHILE SHUTTING THE SUTURES THROUGH. THIS WAS DISCOVERED DURING A TUBEROPLATY PROCEDURE ON (B)(6) 2023. ALL THE BROKEN FRAGMENTS WERE RETRIEVED, AND THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17181198 ↗
• MalfunctionFeb 27, 2023Break

  ON 2/6/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KBCCTT BIOCOMPOSITE KNOTLESS SWIVELOCK EYELET BROKE OFF WHILE TENSIONING. THE REST OF THE ANCHOR, SCREW AND SUTURES REMAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444312 ↗
• MalfunctionMay 9, 2022Break; Mechanical Jam; Output Problem

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AR-2324KBCCTT SWIVELOCK SUTURE, INSIDE THE ANCHOR GOT STUCK, AND WHEN SURGEON PULLED MORE FORCEFULLY IT BROKE. THIS WAS DISCOVERED DURING A RCR AS SURGEON WAS REPAIRING THE SUBSCAPULARIS. SURGEON HAD CUT THE TIGERTAPE OFF THE ANCHOR SO IT HAD NOTHING LOADED INTO THE EYELET. THEN, THE ANCHOR WAS INSERTED, SCREWED INTO THE BONE AND THEN, PASSED THE WORKING STITCH WITH A SCORPION NEEDLE THROUGH THE ROTATOR CUFF. THE SUTURE WAS THEN PASSED DOWN THROUGH THE ANCHOR TO CREATE A KNOTLESS REPAIR. AS SURGEON DID THIS, THE SUTURE DOWN INSIDE THE ANCHOR SEEM TO GET STUCK AND ATTEMPTED TO PULL WITH MORE FORCE THAN WHAT YOU SHOULD HAVE HAD TO. THIS CAUSE THE WORKING STITCH TO BREAK INSIDE THE ANCHOR AND IT COULD NOT BE USED. SURGEON WAS ABLE TO UNSCREW THE ANCHOR AND THEN USED A REGULAR STYLE 4.75MM SWIVELOCK ANCHOR INTO THE SAME TUNNEL. ALL THE SUTURES WERE PASSED AND TIED DOWN SUCCESSFULLY TO THE ROTATOR CUFF. WHILE SURGEON WAS TRYING TO REPAIR THE SUPRASPINATUS TEAR, AFTER MAKING A TUNNEL AND INSERTING ANOTHER AR-2324KBCCTT SWIVELOCK ANCHOR WITH A TIGERTAPE, THE SUTURES PULLED OUT WHEN THE INSERTER SHAFT WAS REMOVED. THE

  Patient problems: Foreign Body In Patient

  MAUDE report 14336244 ↗
• MalfunctionSep 28, 2021Material Frayed

  ON 09/08/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2324KBCCTT LOT: 132416087 KNOTLESS SWIVELOCK, WITH TAPE SHREDDED. THIS WAS DISCOVERED DURING USE IN A ROTATOR CUFF REPAIR ON (B)(6) 2021. THE SURGEON INSERTED THE ANCHOR, AS HE WAS TRYING TO RETRIEVE THE SHUTTLE SUTURE, THE SUTURE FRAYED. THE SURGEON REMOVED THE ENTIRE AR-2324KBCCTT, (ANCHOR AND SUTURES). THIS PORTION OF THE PROCEDURE WAS COMPLETED USING AR-2324KBCT. THE SURGEON USED A SECOND AR-2325KBCTT LOT:132416087, AS HE WAS RUNNING THE REPAIR STITCH THOUGH THE ANCHOR, THE SUTURES CUT IN HALF. THE ANCHOR WAS SECURE AND LEFT INSIDE THE PATIENT AND THE SUTURES WERE CUT AND REMOVED. THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 12540113 ↗
• InjurySep 17, 2020Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE SURGEON EXPERIENCED THE FOLLOWING ISSUES WITH ARTHREX DEVICES, WHEN INSERTING AN AR-2324KBCCT (LOT 10679428) THE SWIVELOCK WAS INSERTED AND UPON REMOVAL OF THE DRIVER, THE PORTION OF THE EYELET THAT CONTAINS THE KNOTLESS MECHANISM REMAINED IN THE CANNULATION OF THE DRIVER. WHEN INSERTING AN AR-2324KBCCTT (LOT 10941879) UPON FINAL TENSIONING OF THE KNOTLESS MECHANISM THE PORTION OF THE EYELET BROKE COMING UP THROUGH THE SCREW, RESULTING IN CUTTING OF THE SUTURE AND REMOVING THE PEEK PORTION OF THE EYELET. THE DISTAL END OF THE EYELET THAT HAS THE FIBERTAPES THROUGH THEM AND THE SCREWS THEMSELVES STAYED IN THE PATIENT FROM EACH ANCHOR. AN AR-1922P GREEN PUNCH HAD BEEN USED TO PREP THE BONE FOR INSERTION. BONE QUALITY OF THE PATIENT WAS REPORTED TO BE GOOD. THE REPORTER STATES THE PATIENT WAS NOT HARMED IN ANY WAY AND THE SPEEDBRIDGE WAS COMPLETED PER TECHNIQUE GUIDE WITH TWO 5.5MM SWIVELOCKS LATERALLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10546281 ↗