Arthrex® AR-2324BCT-2-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867264571), received between Apr 20, 2021 and Sep 9, 2025 — classified as 8 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  AN UNKNOWN ISSUE WITH THE REPORTED DEVICE HAS OCCURRED DURING A KNEE SURGERY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. *** UPDATE CMACKENBACH (B)(6) *** FURTHER INFORMATION WAS RECEIVED. AFTER RIGHT ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY PERFORMED ON (B)(6) 2022 THE PATIENT DEVELOPED PAIN WHEN RUNNING. A SCREW PROTRUSION ON THE GERDY TUBERCLE WAS SUSPECTED, WHICH WAS CONFIRMED WITH A MRI SCAN ON (B)(6) 2023. ON (B)(6) 2024 ANOTHER SURGERY WAS PERFORMED TO REMOVE THE SCREW.

  Patient problems: Pain

  MAUDE report 23006168 ↗
• InjuryFeb 7, 2022Break; Material Frayed; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SHOULDER SURGERY THE SUTURE THREADS CONTAINED IN THE ANCHOR BROKE AFTER SCREWING AND REMOVING THE GREEN HANDLE FROM THE SWIVELOCK. THE THREADS FRAYED AT THE JUNCTION BETWEEN THE EYELET AND THE METAL GUIDE DURING IMPACTION AND SCREWING. THE DEVICE REMAINS IN THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM ANOTHER MANUFACTURER. ACCORDING TO THE CUSTOMER IT WAS NECESSARY TO SWITCH THE SURGICAL TECHNIQUE, BECAUSE THE ANCHOR COULD NOT BE USED TO REPAIR THE CAP DUE TO ABSENCE OF SUTURE. A SECOND SURGERY WAS NOT NECESSARY. UPDATE 25-JAN-2022: THE ANCHOR STAYS IN PATIENT WITHOUT THE BROKEN SUTURES, THEY WERE REMOVED FROM PATIENT. THE SURGEON HAD TO USE ANOTHER ANCHOR FROM ANOTHER MANUFACTURER, JUST NEXT TO THE FIRST ONE TO FINISH THE PROCEDURE. SURGEON HAD TO CHANGE THE SURGICAL TECHNIQUE A LITTLE BIT BECAUSE THE ARTHREX ANCHOR TOOK ONE PLACE ON SHOULDER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13471292 ↗
• InjuryFeb 7, 2022Break; Material Frayed; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SHOULDER ARTHROSCOPY THE SUTURE THREADS CONTAINED IN THE ANCHOR BROKE AFTER SCREWING AND REMOVING THE GREEN HANDLE FROM THE SWIVELOCK. THE THREADS FRAYED AT THE JUNCTION BETWEEN THE EYELET AND THE METAL GUIDE DURING IMPACTION AND SCREWING. DEVICE REMAINED IN THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM ANOTHER MANUFACTURER. A CHANGE OF THE SURGICAL TECHNIQUE WAS NECESSARY BECAUSE THE ANCHOR COULD NOT BE USED TO REPAIR THE CAP DUE TO THE ABSENCE OF SUTURE. IT WAS NOT NECESSARY DO A SECOND SURGERY. UPDATE 25-JAN-2022: THE ANCHOR STAYS IN PATIENT WITHOUT THE BROKEN SUTURES, THEY WERE REMOVED FROM PATIENT. THE SURGEON HAD TO USE ANOTHER ANCHOR FROM ANOTHER MANUFACTURER, JUST NEXT TO THE FIRST ONE TO FINISH THE PROCEDURE. SURGEON HAD TO CHANGE THE SURGICAL TECHNIQUE A LITTLE BIT BECAUSE THE ARTHREX ANCHOR TOOK ONE PLACE ON SHOULDER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13470975 ↗
• InjuryDec 13, 2021Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE SUTURES CONTAINED IN THE ANCHOR BROKE AFTER THE SWIVELOCK BODY WAS REMOVED. BOTH ANCHORS REMAINED INSIDE THE PATIENT AND WERE NOT RETRIEVED. THE SURGEON REPORTED THAT THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM A DIFFERENT MANUFACTURER. IT WAS NECESSARY TO SWITCH THE SURGICAL TECHNIQUE TO USE THE ANCHOR FROM ANOTHER MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12984287 ↗
• InjuryDec 13, 2021Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE SUTURES CONTAINED IN THE ANCHOR BROKE AFTER THE SWIVELOCK BODY WAS REMOVED. BOTH ANCHORS REMAINED INSIDE THE PATIENT AND WERE NOT RETRIEVED. THE SURGEON REPORTED THAT THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM A DIFFERENT MANUFACTURER. IT WAS NECESSARY TO SWITCH THE SURGICAL TECHNIQUE TO USE THE ANCHOR FROM ANOTHER MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12984226 ↗
• InjuryDec 13, 2021Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE SUTURES CONTAINED IN THE ANCHOR BROKE AFTER THE SWIVELOCK BODY WAS REMOVED. BOTH ANCHOR REMAINED INSIDE THE PATIENT AND WERE NOT RETRIEVED. THE SURGEON REPORTED THAT THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM A DIFFERENT MANUFACTURER. IT WAS NECESSARY TO SWITCH THE SURGICAL TECHNIQUE TO USE THE ANCHOR FROM ANOTHER MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12984214 ↗
• InjuryDec 13, 2021Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE SUTURES CONTAINED IN THE ANCHOR BROKE AFTER THE SWIVELOCK BODY WAS REMOVED. BOTH ANCHORS REMAINED INSIDE THE PATIENT AND WERE NOT RETRIEVED. THE SURGEON REPORTED THAT THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM A DIFFERENT MANUFACTURER. IT WAS NECESSARY TO SWITCH THE SURGICAL TECHNIQUE TO USE THE ANCHOR FROM ANOTHER MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12984170 ↗
• InjuryDec 13, 2021Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE SUTURES CONTAINED IN THE ANCHOR BROKE AFTER THE SWIVELOCK BODY WAS REMOVED. THE REPORTED ANCHOR REMAINED INSIDE THE PATIENT AND WAS NOT RETRIEVED. THE SURGEON REPORTED THAT THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM A DIFFERENT MANUFACTURER. IT WAS NECESSARY TO SWITCH THE SURGICAL TECHNIQUE TO USE THE ANCHOR FROM ANOTHER MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12984088 ↗
• MalfunctionApr 22, 2021Break

  IT WAS REPORTED THAT AT THE END OF THE SHOULDER ROTATOR CUFF REPAIR SURGERY THE SECOND INSIDE SUTURES OF THE DEVICES BROKE INSIDE THE PATIENT. AT THE END OF THE SURGERY, WHEN THE SECOND TIGERTAIL HAS TO BE REMOVED FROM THE EYELET AND THROUGH THE SCREW, THE SUTURES BROKE. THE SURGEON PULLED ON ONE SIDE OF THE SUTURE TO REMOVE IT TOTALLY BUT ONLY ONE HALF CAME OUT, THE SECOND HALF STAYED INSIDE THE SCREW. UPDATE 22-APR-2021: IT WAS CONFIRMED THAT THE FIBERTAIL & TIGERTAIL SUTURES OF THE DEVICES BROKE INSIDE THE PATIENT, WHICH ARE NOT THE PRIMARY REPAIR. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11711784 ↗
• MalfunctionApr 21, 2021Break

  IT WAS REPORTED THAT AT THE END OF THE SHOULDER ROTATOR CUFF REPAIR SURGERY THE SECOND INSIDE SUTURES OF THE DEVICES BROKE INSIDE THE PATIENT. AT THE END OF THE SURGERY, WHEN THE SECOND TIGERTAIL HAS TO BE REMOVED FROM THE EYELET AND THROUGH THE SCREW, THE SUTURES BROKE. THE SURGEON PULLED ON ONE SIDE OF THE SUTURE TO REMOVE IT TOTALLY BUT ONLY ONE HALF CAME OUT, THE SECOND HALF STAYED INSIDE THE SCREW.

  Patient problems: Foreign Body In Patient

  MAUDE report 11699577 ↗
• MalfunctionApr 21, 2021Break; Difficult to Remove

  IT WAS REPORTED THAT AT THE END OF THE SHOULDER ROTATOR CUFF REPAIR SURGERY THE SECOND INSIDE SUTURES OF THE DEVICES BROKE INSIDE THE PATIENT. AT THE END OF THE SURGERY, WHEN THE SECOND TIGERTAIL HAS TO BE REMOVED FROM THE EYELET AND THROUGH THE SCREW, THE SUTURES BROKE. THE SURGEON PULLED ON ONE SIDE OF THE SUTURE TO REMOVE IT TOTALLY BUT ONLY ONE HALF CAME OUT, THE SECOND HALF STAYED INSIDE THE SCREW.

  Patient problems: Foreign Body In Patient

  MAUDE report 11699568 ↗
• MalfunctionApr 20, 2021Break

  IT WAS REPORTED THAT AT THE END OF THE SHOULDER ROTATOR CUFF REPAIR SURGERY THE SECOND INSIDE SUTURES OF THE DEVICES BROKE INSIDE THE PATIENT. AT THE END OF THE SURGERY, WHEN THE SECOND TIGERTAIL HAS TO BE REMOVED FROM THE EYELET AND THROUGH THE SCREW, THE SUTURES BROKE. THE SURGEON PULLED ON ONE SIDE OF THE SUTURE TO REMOVE IT TOTALLY BUT ONLY ONE HALF CAME OUT, THE SECOND HALF STAYED INSIDE THE SCREW.

  Patient problems: Foreign Body In Patient

  MAUDE report 11695951 ↗
• MalfunctionApr 20, 2021Break; Difficult to Remove

  IT WAS REPORTED THAT AT THE END OF THE SHOULDER ROTATOR CUFF REPAIR SURGERY THE SECOND INSIDE SUTURES OF THE DEVICES BROKE INSIDE THE PATIENT. AT THE END OF THE SURGERY, WHEN THE SECOND TIGERTAIL HAS TO BE REMOVED FROM THE EYELET AND THROUGH THE SCREW, THE SUTURES BROKE. THE SURGEON PULLED ON ONE SIDE OF THE SUTURE TO REMOVE IT TOTALLY BUT ONLY ONE HALF CAME OUT, THE SECOND HALF STAYED INSIDE THE SCREW.

  Patient problems: Foreign Body In Patient

  MAUDE report 11695899 ↗