Arthrex® AR-2324BCM-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888867098039), received between May 16, 2022 and Sep 25, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896934 ↗
• MalfunctionJul 27, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50017429 ↗
• MalfunctionJul 19, 2024Break; Break

  ON 24 JUNE 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT 2 X AR-2324BCM-1 BIO-COMP SWVLK SP, 4.75X24.5MM WERE REPORTED TO HAVE FAILED DURING USE. THIS OCCURRED ON 24 JUNE 2024 IN BRAEMAR HOSPITAL DURING A LEFT ARTHROSCOPIC BICEPS TENODESIS AND ROTATOR CUFF REPAIR WITH SUB ACROMIAL DECOMPRESSION. IT WAS REPORTED THE SWIVELOCK ANCHOR WAS LOADED WITH X FOUR TAILS OF SUTURETAPE AR-7501. THE ANCHOR WAS INSERTED INTO THE LATERAL ASPECT OF THE HUMERAL HEAD USING A MALLET. WITH EACH TAP OF THE MALLET ON THE SWIVELOCK ONLY SMALL PROGRESS WAS MADE INTO THE CORTICAL BONE, MORE PRESSURE WAS APPLIED WITH EACH TAP OF THE MALLET WITH THE SAME PROGRESS. BY THIS STAGE IT WAS DECIDED TO REMOVE THE SWIVELOCK FROM THE BONE AS SOMETHING WAS NOT RIGHT WITH THE USUAL INSERTION OF A SELF-PUNCHING SWIVELOCK. THE SURGEON TRIED TO REMOVE THE SWIVELOCK, HOWEVER THE METAL EYELET HAD ENGAGED INTO THE BONE DEEP ENOUGH SO THAT IT COULD NOT BE REMOVED AND THE SWIVELOCK ANCHOR HAD BROKEN IN HALF. THE SURGEON ATTEMPTED TO REMOVE THE METAL EYELET BUT IT WAS BURIED TOO DEEP INTO THE HUMERAL HEAD. ANOTHER SWIVELOCK ANCHOR WAS USED, BUT WITH THE SAME RESULT, SO A PUNCH AND TAP WERE USED WHICH RESULTED I

  Patient problems: Foreign Body In Patient

  MAUDE report 19782595 ↗
• MalfunctionJul 17, 2024Break; Break

  ON 24 JUNE 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT 2 X AR-2324BCM-1 BIO-COMP SWVLK SP, 4.75X24.5MM WERE REPORTED TO HAVE FAILED DURING USE. THIS OCCURRED ON (B)(6) 2024 IN (B)(6) HOSPITAL DURING A LEFT ARTHROSCOPIC BICEPS TENODESIS AND ROTATOR CUFF REPAIR WITH SUB ACROMIAL DECOMPRESSION. IT WAS REPORTED THE SWIVELOCK ANCHOR WAS LOADED WITH X FOUR TAILS OF SUTURETAPE AR-7501. THE ANCHOR WAS INSERTED INTO THE LATERAL ASPECT OF THE HUMERAL HEAD USING A MALLET. WITH EACH TAP OF THE MALLET ON THE SWIVELOCK ONLY SMALL PROGRESS WAS MADE INTO THE CORTICAL BONE, MORE PRESSURE WAS APPLIED WITH EACH TAP OF THE MALLET WITH THE SAME PROGRESS. BY THIS STAGE IT WAS DECIDED TO REMOVE THE SWIVELOCK FROM THE BONE AS SOMETHING WAS NOT RIGHT WITH THE USUAL INSERTION OF A SELF-PUNCHING SWIVELOCK. THE SURGEON TRIED TO REMOVE THE SWIVELOCK, HOWEVER THE METAL EYELET HAD ENGAGED INTO THE BONE DEEP ENOUGH SO THAT IT COULD NOT BE REMOVED AND THE SWIVELOCK ANCHOR HAD BROKEN IN HALF. THE SURGEON ATTEMPTED TO REMOVE THE METAL EYELET BUT IT WAS BURIED TOO DEEP INTO THE HUMERAL HEAD. ANOTHER SWIVELOCK ANCHOR WAS USED, BUT WITH THE SAME RESULT, SO A PUNCH AND TAP WERE USED WHICH RESULTED IN

  Patient problems: Foreign Body In Patient

  MAUDE report 19763986 ↗
• MalfunctionJun 11, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE DEVICE BLOCKED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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. **22-FEB-2023 UPDATE (B)(6). FURTHER INFORMATION WERE PROVIDED THAT THE DEVICE COULD NOT BE TURNED ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510763 ↗
• MalfunctionApr 29, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SURGERY ON THE ROTATOR CUFF TWO DEVICES BECAME BENT WHEN THE SURGEON INSERTED THEM. THE SURGEON REPORTED THAT THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202934 ↗
• MalfunctionApr 10, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE SURGEON WAS NOT ABLE TO USE THE IMPLANT BECAUSE IT WAS IMPOSSIBLE TO IMPACT IT. IT DID NOT BREAK IN THE PATIENT, THE SURGEON PRESSED ON SOMETHING AND NOTHING CAME OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 (B)(6) 2022 DW: FURTHER INFORMATION WAS PROVIDED THAT THE IMPLANT DID NOT DETACH FROM THE DRIVER, AND NOTHING BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19081958 ↗
• MalfunctionMar 8, 2024Break; Break

  IT WAS REPORTED THAT THE IMPLANT BROKE WHEN THE SCREW TIP IMPACTED THE METAL PART OF THE ANCHOR, WHICH MADE THE SCREW INSERTION IMPOSSIBLE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18869810 ↗
• MalfunctionDec 26, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE WIRES JAMMED IN THE EYELET CAUSING THE ANCHOR TO PULL OUT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 NROE 12-DEC-2023: FURTHER INFORMATION REVEALED THAT THE WIRE JAMMED IN THE EYELET, CAUSING THE ANCHOR TO PULL OUT OF THE BONE. NO PART OF THE DEVICE BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18394087 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF SURGERY, THE INSERTER OF THE DEVICE BROKE/BENT. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18139079 ↗
• MalfunctionSep 27, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE ANCHOR (AR-2324BCM-1) COULD NOT BE SCREWED IN EVEN THOUGH THE BONE WAS PREPARED BEFORE. ALSO THE ANCHOR ALMOST RIPS OUT THE THREAD WHEN BEING INSERTED. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE TIP OF THE ANCHOR WAS DEFORMED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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: Failure of Implant

  MAUDE report 17824740 ↗
• MalfunctionSep 27, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE ANCHOR COULD NOT BE SCREWED IN EVEN THOUGH THE BONE WAS PREPARED BEFORE. ALSO THE ANCHOR ALMOST RIPS OUT THE THREAD WHEN BEING INSERTED. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE TIP OF THE ANCHOR WAS DEFORMED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17824719 ↗
• InjuryJul 12, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER A ROTATOR CUFF REPAIR SURGERY THE PATIENT HAS AN INFECTION. DUE TO THE INFECTION THE IMPLANTED ITEMS WILL BE REMOVED IN REVISION SURGERY ON (B)(6) 2023. THE FOLLOWING DEVICES WERE USED OR IMPLANTED IN THE INITIAL SURGERY: AR-6530-1 LOT: 829187258, AR-13995N-1 LOT: 15068024, AR-1927BCT-1 LOT: 14146766, AR-2324BCM-1 LOT: 15046069. UPDATE SWIT 27-JUN-2023: THE INITIAL SURGERY WAS PERFORMED LAST WEEK. THE INFECTION WAS OBSERVED DURING THE WEEKEND (ON (B)(6) 2023). THE INTERVENTION IS PLANNED FOR ON (B)(6) 2023. THE SURGEON IS PLANNING TO REMOVE EVERYTHING WITHOUT REPLACING IMPLANTS. UPDATE SWIT 30-JUN-2023: THE IMPLANTS WERE SUCCESSFULLY REMOVED DURING REVISION SURGERY. THEY ARE AWAITING THE RESULTS OF THE BACTERIOLOGICAL SAMPLE. THE PATIENT WILL RECEIVE AN ANTIBIOTIC THERAPY AND ONCE THE INFECTION HAS BEEN RESOLVED, HE WILL WEAR STOCKS.

  Patient problems: Unspecified Infection

  MAUDE report 17304400 ↗
• MalfunctionJul 3, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY A MALFUNCTION OCCURRED WITH THE DEVICE. NO PART OF THE DEVICE BROKE OFF. 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. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 09-JUN-2023: FURTHER INFORMATION WAS PROVIDED THAT THE ANCHOR OF THE DEVICE WAS FAULTY. DURING RELEASE OF THE ANCHOR, WHICH WAS BEING USED AS THE 2ND ANCHOR IN THE 2ND ROW OF SUTURES, IT JAMMED AND TORE OFF THE ENTIRE SUTURE PREVIOUSLY MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245887 ↗
• MalfunctionMay 16, 2022Break

  IT WAS REPORTED THAT DURING SURGERY THE METAL TIP OF THE DEVICE BROKE OFF AND DAMAGED ALL EXISTING THREADS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407291 ↗