Arthrex® AR-2324KBCSPRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00888867384538), received between Oct 26, 2023 and Feb 6, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Break

  ON 16-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-2324KBCSP BIOCOMPOSITE KNOTLESS SWIVELOCK ANCHOR WAS OPENED AND, DURING PREPARATION IN NORMAL BONE FOLLOWING THE STANDARD TECHNIQUE, THE EYELET BROKE IN HALF. A STANDARD SWIVELOCK WAS SUBSEQUENTLY OPENED, AND THE SITE WAS REPUNCHED TO COMPLETE THE PROCEDURE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 20-JAN-2026: THIS EVENT OCCURRED DURING A ROTATOR CUFF REPAIR PROCEDURE. ALL DETACHED EYELET FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED USING AN AR-2324BCC BIOCOMPOSITE SWIVELOCK C. IT IS UNKNOWN WHETHER A CASE DELAY OCCURRED OR IF ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277177 ↗
• MalfunctionOct 15, 2025Break; Break

  ON 10/06/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE SUTURE EYELET OF AN AR-2324KBCSP BIOCOMPOSITE KNOTLESS SWIVELOCK ANCHOR BROKE WHILE ATTEMPTING TO INSERT THE ANCHOR INTO THE LATERAL ROW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO FRAGMENTS WERE RETAINED IN THE PATIENT. THIS OCCURRED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 10/08/2025: ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH A REPLACEMENT AR-2324KBCSP BIOCOMPOSITE KNOTLESS SWIVELOCK ANCHOR. THE INCIDENT DID NOT RESULT IN ANY SURGICAL DELAY, ADDITIONAL ANESTHESIA, OR REPORTED ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303883 ↗
• MalfunctionAug 13, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2324KBCSP KNOTLESS SWIVELOK ANCHOR EYELET AND ANCHOR BROKE OFF WHILE BEING INSERTED. ALL FRAGMENTS ABLE TO BE REMOVED. THE CASE WAS COMPLETED USING ANOTHER ANCHOR. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. 4 MINUTE DELAY TO CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795044 ↗
• MalfunctionAug 7, 2025Break; Break

  ON 7/18/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-2324KBCSP 4.75 MM BIOCOMPOSITE KNOTLESS SWIVELOCK ANCHOR HAD AN ISSUE DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025. WHEN THE SURGEON WAS INSERTING IT INTO THE BONE AT A PERPENDICULAR ANGLE, UPON TAPPING, THE EYLET BROKE INSIDE THE PATIENT. THE SURGEON WAS ABLE TO REMOVE ALL FRAGMENTS FROM THE PATIENT, AND THERE WAS NO HARM. THE COMPLAINT DEVICE WAS DISCARDED, AND NO PICTURES WERE TAKEN. ANOTHER AR-2324KBCSP 4.75 MM BIOCOMPOSITE KNOTLESS SWIVELOCK ANCHOR WITH THE SAME LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE CASE WAS SLIGHTLY DELAYED BY UNDER 15 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22736845 ↗
• MalfunctionAug 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3633SP FIBERTAK SP SUTURE ANCHOR WAS USED FOR THE MEDIAL ROW DURING A SUPRASPINATUS TENDON REPAIR ARTHROSCOPIC PROCEDURE ON (B)(6) 2025. THE ANCHOR PULLED OUT TWICE DURING PLACEMENT, EVEN AFTER BEING RELOADED AND REINSERTED INTO THE SAME HOLE IN AN ATTEMPT TO SET IT AGAIN. THE AR-3650DS DRILL WAS USED WITH THE ORANGE 3.5 REUSABLE DRILL GUIDE, AND THE ANCHOR WAS PLACED ACCORDING TO STANDARD TECHNIQUE. BONE QUALITY WAS MODERATE. AN AR-1927PST-3 ANCHOR WAS INSERTED IN THE SAME HOLE TO COMPLETE THE MEDIAL FIXATION. A 10-MINUTE DELAY OCCURRED. FOR THE LATERAL ROW, AN AR-2324KBCSP KNOTLESS BIOCOMPOSITE SWIVELOCK SP ANCHOR WAS USED, AND THE EYELET FRACTURED THROUGH THE SIDE UPON INSERTION. A TOTAL OF THREE SUTURE TAPES WERE LOADED INTO THE EYELET. THE HOLE WAS PRE-PUNCHED WITH THE SILVER PUNCH, AND LIGHT TAPS WERE USED TO INITIATE INSERTION. BONE QUALITY WAS MODERATE TO HARD. AN ADDITIONAL AR-2324KBCSP ANCHOR WAS USED TO COMPLETE THE LATERAL FIXATION. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 07/23/2025: THE CASE WAS DELAYED A TOTAL OF TEN MINUTES DUE TO BOTH FAILED ANCHORS, WITH TEN MINU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720398 ↗
• MalfunctionApr 21, 2025Break; Break

  ON 04/08/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2324KBCSP 4.75 MM BIOCOMPOSITE KNOTLESS SWIVELOCK ANCHOR, SELF PUNCHING WITH BLUE #2 SUTURE HAD THE PEEK EYELET BREAK INTO PIECES DURING INSERTION OF THE IMPLANT. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER AR-2324KBCSP 4.75 MM BIOCOMPOSITE KNOTLESS SWIVELOCK ANCHOR WITHOUT ISSUES. THE CASE WAS DELAYED LESS THAN 15 MINUTES WITH NO ADDED ANESTHESIA ADMINISTERED TO THE PATIENT. NO ADVERSE EFFECTS WERE REPORTED. THIS WAS DISCOVERED DURING A ROTATOR CUFF SHOULDER SCOPE PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875962 ↗
• MalfunctionApr 2, 2025Break; Break

  ON 3/13/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KBCSP 4.75 MM BIOCOMPOSITE KNOTLESS SWIVELOCK SUTURE BECAME LOOSE AFTER BEING HIT WITH A MALLET DURING INSERTION, ADDITIONALLY, THE EYELET OF THE SWIVELOCK BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 3/31/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753727 ↗
• MalfunctionFeb 25, 2025Break; Break

  ON 02/13/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KBCSP KNOTLESS BIOCOMPOSITE SWIVELOCK SP HAD THE EYELET BREAK. NO PIECES BROKE OFF IN THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459364 ↗
• MalfunctionFeb 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 01/17/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3641SP SELF-PUNCHING KNOTLESS 2.6 FIBERTAK ANCHOR PULLED OUT. AFTER USING AN AR-3650DS DISPOSABLES KIT FOR 2.6 FIBERTAK TO IMPLANT THE AR-3641SP SELF-PUNCHING KNOTLESS 2.6 FIBERTAK, THE REPAIR SUTURE WAS PASSED THROUGH THE UPPER BORDER OF THE SUBSCAP WITH A SCORPION, AND THE REPAIR SUTURE WAS CONVERTED. THEN IT WAS TENSIONED NO TANGLES. WITH ABOUT 1CM OF SLACK LEFT IN THE TENSIONING LIMB, THE ANCHOR PULLED OUT. THE ANCHOR WAS CUT OUT, LEAVING NO RESIDUAL IMPLANTS IN THE PATIENT. AT THIS POINT, THE SUBSCAP WAS DEBRIDED AND LEFT ALONE. LATER IN THE PROCEDURE, THE SUPRASPINATUS WAS ADDRESSED USING AN AR-3652SP FIBERTAK RC SUTURE ANCHOR. ALL SUTURES WERE PASSED AND THEN BROUGHT OVER TO THE LATERAL ANCHOR ON AN AR-2324KBCSP SWIVELOCK. ALL SUTURES FROM THE REPAIR WERE CUT, AND THE INITIAL REPAIR WAS COMPLETED. WHILE SHUTTLING THE REPAIR SUTURE THROUGH THE KNOTLESS MECHANISM, THE ENTIRE AR-2324KBCSP SWIVELOCK ANCHOR AND EYELET PULLED OUT OF THE BONE. ALL PARTS OF THE ANCHOR WERE REMOVED FROM THE PATIENT. THE SUTURES FROM THE MEDIAL ANCHOR WERE CUT OUT, BUT THE ANCHOR BODY WAS WELL FIXED IN BONE AND REMAINED THER

  Patient problems: Foreign Body In Patient

  MAUDE report 21344661 ↗
• MalfunctionJan 13, 2025Break; Break

  ON 12/17/2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-2324KBCSP SWIVELOCK HAD THE SELF-PUNCHING MECHANISM BREAK DURING A LATERAL ROW. THE EYELET BROKE INTO ONE PIECE AND WAS RETRIEVED FROM THE PATIENT. TO COMPLETE THE CASE, ANOTHER AR-2324KBCSP SWIVELOCK WAS USED WITH THE SAME LOT NUMBER. THE CASE WAS DELAYED LESS THAN 15 MINUTES DUE TO THE ISSUE. THIS WAS DISCOVERED DURING A ROTATOR CUFF PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138685 ↗
• MalfunctionNov 12, 2024Break; Break

  ON 10/30/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-06698166 THAT AN AR-2324KBCSP SWIVELOCK ANCHOR BROKE. THIS OCCURRED DURING USE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668276 ↗
• MalfunctionNov 7, 2024Break; Break

  ON 10/25/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-2324KBCSP SWIVELOCKS PLASTIC SPADE TIP BROKE. THIS OCCURRED DURING A CASE WHEN THE PLASTIC SPADE TIP BROKE WHEN MALLETING INTO THE PATIENT'S BONE.

  Patient problems: Insufficient Information

  MAUDE report 20633850 ↗
• MalfunctionOct 15, 2024Break; Break

  ON 10/7/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KBCSP KNOTLESS BIOCOMPOSITE SWIVELOCK SP EYELET BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 20455284 ↗
• MalfunctionSep 11, 2024Positioning Failure; Positioning Failure

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KBCSP KNOTLESS BIOCOMPOSITE SWIVELOCK SP MECHANISM WAS NOT LOCKING. THE KNOTLESS BIOCOMPOSITE SWIVELOCK SP CONVERTED NORMALLY; HOWEVER, THEN THE SURGEON TENSIONED, THE LOCKING MECHANISM KEPT SLIPPING. WITH THE USE OF A GRASPER, IT WAS PULLED BACK, AND THE KNOTLESS MECHANISM PORTION WAS UNDONE. THE MECHANISM DID NOT FULLY UNLOCK BUT IT WAS NOT FULLY SET. THE ANCHOR WAS LEFT IMPLANTED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 20189070 ↗
• MalfunctionSep 10, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KBCSP BIOCOMPOSITE SWIVELOCK SP EYELET BROKE. WHEN THE SURGEON WAS GOING TO MALLET IN THE ANCHOR, THE EYELET KEPT LOOSENING UP. AFTER RESETTING THE EYELET, THE SURGEON TRIED TO PUNCH A HOLE WITH THE SILVER TAP JUST TO BREAK THE CORTICES, BUT WHEN MALLETING THE ANCHOR IN AGAIN, THE EYELET SNAPPED OFF. THE BROKEN FRAGMENT WAS REMOVED. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20180084 ↗
• MalfunctionSep 6, 2024Break; Break

  ON (B)(6) 2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-2324KBCSP SWIVELOCK SHUTTLING SUTURE BROKE AND AN AR-1204AF-95 FLIPCUTTER® II BUTTON WOULD NOT DEPLOY. BOTH COMPLAINT DEVICES WERE REPLACED WITH ANOTHER DEVICE WITHOUT ANY ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 8/19/2024: THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE. THERE WAS NO CASE DELAY REPORTED. THE BROKEN SUTURE OF THE AR-2324KBCSP SWIVELOCK WAS REMOVED FROM THE PATIENT. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158963 ↗
• MalfunctionAug 9, 2024Break; Break

  ON 8/2/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KBCSP KNOTLESS BIOCOMPOSITE SWIVELOCK SP EYELET BROKE DURING INSERTION. THE CASE WAS COMPLETED USING A SECOND ANCHOR. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19953690 ↗
• MalfunctionJul 17, 2024Break; Break

  ON 06/26/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS (B)(4) THAT AN AR-2324KBCSP SWIVELOCK, SP BC KL 4.75MM, HAD AN ISSUE DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2024 WHILE USING THE FIBERTAK RC AND 4.75 KNOTLESS SWIVELOCK SELF-PUNCHING ANCHORS IN A SPEEDBRIDGE CONSTRUCT. WHILE PLACING THE FIRST LATERAL ROW OF THE SELF-PUNCHING ANCHOR OF THE AR-2324KBCSP SWIVELOCK INTO THE BONE, THE SURGEON COULD NOT BREACH THE CORTEX SUCCESSFULLY. WHILE PERPENDICULARLY MALLETING THE ANCHOR, THE PEEK TIP FRACTURED ON THE BONE. THEY RECOVERED THE ANCHOR FROM THE JOINT, BUT IT WAS UNUSABLE AFTERWARD. ANOTHER ANCHOR WAS OPENED, AND THE PUNCH WAS USED TO BREACH THE CORTEX, AND THE ANCHOR WORKED SUCCESSFULLY. NO SECONDARY SURGERY IS NEEDED. THIS OCCURRED DURING USE AND HAD NO EFFECT ON THE PATIENT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 7/2/2024: THERE WAS A CASE DELAY OF 11 MINUTES DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761265 ↗
• MalfunctionJul 8, 2024Break; Break

  ON 6/13/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2324KBCSP SP SWIVELOCK EYELET BROKE DURING INSERTION. ALL THE FRAGMENTS WERE REMOVED AND A NEW AR-2324KBCSP SP SWIVELOCK WAS USED TO COMPLETE THE CASE. THE CASE WAS NOT DELAYED. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19690706 ↗
• MalfunctionJun 10, 2024Crack; Crack

  ON 5/16/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2324KBCSP SWIVELOCK EYELET CRACKED DURING INSERTION BUT DID NOT BREAK. THE EYELET WAS REMOVED, AND ANOTHER AR-2324KBCSP SWIVELOCK WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505479 ↗
• MalfunctionMay 23, 2024Break; Break

  ON 4/25/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KBCSP KNOTLESS BIOCOMPOSITE SWIVELOCK SP EYELET BROKE DURING INSERTION. ALL BROKEN FRAGMENTS WERE REMOVED SUCCESSFULLY. THE CASE WAS COMPLETE WITH ANOTHER AR-2324KBCSP KNOTLESS BIOCOMPOSITE SWIVELOCK SP. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19388647 ↗
• MalfunctionApr 25, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KBCSP SWIVELOCK SP ANCHOR COULD NOT BE IMPLANTED. THE SURGEONS ATTEMPTED TO SELF-PUNCH THE ANCHOR, BUT THE PATIENT'S BONE QUALITY WAS TOO HARD. AFTER MULTIPLE ATTEMPTS WITH DIFFERENT ANGLES, A GREEN PUNCH WAS USED TO CREATE A PILOT HOLE, BUT THE ANCHOR STILL WOULDN'T GO IN. THE TUBEROSITY ENDED UP FRACTURING. ANOTHER AR-2324KBCSP SWIVELOCK SP WAS OPENED BUT ENDED UP BREAKING INTO PIECES DURING INSERTION. AFTER DEBRIDEMENT, THE CASE WAS COMPLETED USING TWO BIOCOMPOSITE KNOTLESS SWIVELOCK. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024.

  Patient problems: Bone Fracture(s)

  MAUDE report 19182475 ↗
• MalfunctionApr 25, 2024Failure to Advance; Failure to Advance

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KBCSP SWIVELOCK SP ANCHOR COULD NOT BE IMPLANTED. THE SURGEONS ATTEMPTED TO SELF-PUNCH THE ANCHOR, BUT THE PATIENT'S BONE QUALITY WAS TOO HARD. AFTER MULTIPLE ATTEMPTS WITH DIFFERENT ANGLES, A GREEN PUNCH WAS USED TO CREATE A PILOT HOLE, BUT THE ANCHOR STILL WOULDN'T GO IN. THE TUBEROSITY ENDED UP FRACTURING. ANOTHER AR-2324KBCSP SWIVELOCK SP WAS OPENED BUT ENDED UP BREAKING INTO PIECES DURING INSERTION. AFTER DEBRIDEMENT, THE CASE WAS COMPLETED USING TWO BIOCOMPOSITE KNOTLESS SWIVELOCK. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024.

  Patient problems: Bone Fracture(s)

  MAUDE report 19181406 ↗
• MalfunctionApr 5, 2024Crack; Crack

  ON 03/15/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KBCSP SWIVELOCK, SP BC KL 4.75MM WAS PLACED INTO THE BONE AND UPON GENTLE TAPS THE ANCHOR EYELET BROKE. ADDITIONAL INFORMATION RECEIVED ON 3/20/2024: THIS WAS DISCOVERED DURING AN RCR PROCEDURE. THE ANCHOR EYELET CRACKED BUT DID NOT COMPLETELY BREAK, THERE WERE NO LOOSE FRAGMENTS. THE CASE WAS COMPLETED USING ANOTHER AR-2324KBCSP SWIVELOCK. THE CASE WAS ONLY DELAYED LONG ENOUGH TO OPEN A NEW ANCHOR AND REINSERT IT. ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051518 ↗
• MalfunctionMar 14, 2024Break; Break

  ON 2/29/2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-2324KBCSP SWIVELOCK EYELET BROKE DURING INSERTION INTO THE BONE. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING AN AR-2324BCT-2 BIOCOMPOSITE SWIVELOCK. THERE WAS A ONE-MINUTE DELAY WITH NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18905960 ↗