Arthrex® AR-2323BCT-2-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888867264557), received between Nov 22, 2021 and Oct 28, 2024 — classified as 11 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE SURGEON WAS PERFORMING THE SUTUREBRIDGE TECHNIQUE USING SWIVELOCK 5,5MM ANCHORS FOR THE LATERAL RAW. AFTER IMPACTING THE ANCHOR AND RETRIEVING THE BLUE GUIDE THE FIBERWIRE SUTURES CAME OUT AS WELL. THE FIBERWIRE SUTURES WERE NOT HOLD IN THE EYELET. IT HAPPENED WITH TWO ANCHORS WITH THE SAME LOT NUMBER. THE SCREW OF SWIVELOCK 5,5 WAS WELL PLACED AND BLOCKED THE SUTURES OF MEDIAL, SO THE ANCHORS STAYED IN THE PATIENT. THERE WAS NO NEED TO REPAIR THE EARS OF THE ROTATOR CUFF THIS TIME, SO THERE WAS NO NEED TO USE THE FIBER WIRES OF THE SWIVELOCK ANCHORS. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICES. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20549378 ↗
• MalfunctionOct 24, 2024Positioning Failure; Fitting Problem; Positioning Failure; Fitting Problem

  IT WAS REPORTED THAT DURING A SURGERY THE SURGEON WAS USING A SWIVELOCK ANCHOR AND THE FIBERWIRE SUTURES WERE NOT PRELOADED. AFTER IMPACTING THE ANCHOR AND RETRIEVING THE BLUE GUIDE THE FIBERWIRE SUTURES CAME OUT AS WELL. THE FIBERWIRE SUTURES WERE NOT HOLD IN THE EYELET. IT HAPPENED WITH TWO ANCHORS WITH THE SAME LOT NUMBER. THE SCREW OF SWIVELOCK 5,5 WAS WELL PLACED AND BLOCKED THE SUTURES OF MEDIAL, SO THE ANCHORS STAYED IN THE PATIENT. THE USED ANCHOR WAS IMPLANTED WITH NO DAMAGE TO THE PATIENT. THE SURGEON DID NOT NEED TO USE THE FIBERWIRE (WHICH WERE NOT PRELOADED) FOR THESE TWO CASES. NO FURTHER INFORMATION RECEIVED.

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

  MAUDE report 20524435 ↗
• InjuryMar 1, 2023Break

  IT WAS REPORTED THAT DURING A SHOULDER THE SUTURE THREADS CONTAINED IN THE ANCHOR BROKE CLEANLY AFTER SCREWING AND REMOVING THE BLUE HANDLE OF THE SWIVELOCK. THE ANCHOR REMAINED FIXATED IN THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM ANOTHER MANUFACTURER. DUE TO THE CHANGE OF THE DEVICE A DIFFERENT TECHNIQUE WAS NECESSARY TO FINISH THE SURGERY SUCCESSFULLY. NO FURTHER INFORMATION WERE PROVIDED BY THE CUSTOMER WHAT KIND OF TECHNIQUE CHANGE HAS BEEN PERFORMED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16459033 ↗
• MalfunctionMar 14, 2022Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR THE INTERNAL WIRES BROKE WHILE THE SURGEON WAS TIGHTENING THE KNOTS. THE BROKEN WIRE COULD NOT BE RETRIEVED AND REMAINED INSIDE THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13758091 ↗
• 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 13471305 ↗
• InjuryFeb 7, 2022Break; Material Frayed

  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.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13471068 ↗
• InjuryFeb 7, 2022Material Frayed

  IT WAS REPORTED THAT DURING A ROTATOR CUFF 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 CUSTOMER IT WAS NECESSARY TO SWITCH THE SURGICAL TECHNIQUE, BECAUSE THE ANCHOR COULD NOT BE USED TO REPAIR THE CAP DUE TO THE ABSENCE OF SUTURE. IT WAS NOT NECESSARY TO 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: Foreign Body In Patient

  MAUDE report 13471015 ↗
• MalfunctionFeb 7, 2022Break; Difficult to Remove

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SHOULDER ARTHROSCOPY TWO ANCHORS AR-2323BCT-2-1 WERE USED. THE SUTURES WERE DAMAGED AFTER THE ANCHOR WAS PLACED AND THREE SUTURES BROKE. SURGEON HAD DIFFICULTIES TO REPAIR THE PATIENT'S ROTATOR CUFF. HE COULDN'T SQUEEZE AS HARD AS HE WANTED TO. THE ANCHOR WITH THE BROKEN SUTURES WERE NOT RETRIEVED AND REMAINS IN PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 19-JAN-2022: THE BROKEN SUTURES AND THE ANCHOR, WHERE THE SUTURES BROKE, REMAINS IN PATIENT. IT WAS NOT RETRIEVED. AND WITH THIS ANCHOR THE SURGERY WAS FINISHED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13470959 ↗
• MalfunctionJan 24, 2022Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY THE DEVICE BROKE WHEN IT HIT THE BONE. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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.

  Patient problems: Foreign Body In Patient

  MAUDE report 13333463 ↗
• 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 12984300 ↗
• 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 12984246 ↗
• 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 12984227 ↗
• 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 12984225 ↗
• 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 12984124 ↗
• 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 12984103 ↗
• 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 12984057 ↗
• MalfunctionNov 22, 2021Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY MULTIPLE WIRES BROKE AS SOON AS THE SURGEON REMOVED THE IMPLANT GUIDE FROM THE SWIVELOCK. THE WIRES BROKE AT THE JUNCTION OF THE WIRE COLOR CHANGE. THE ANCHORS REMAINED INSIDE THE PATIENT WITHOUT BEING USED FOR REPAIR. OTHER TUNNELS HAD TO BE DRILLED AND THE SURGERY WAS FINISHED WITH A DIFFERENT APPROACH AND A DIFFERENT DEVICE FROM ANOTHER MANUFACTURER.

  Patient problems: Insufficient Information

  MAUDE report 12853844 ↗