Arthrex® AR-2424PHSRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888867443624), received between Apr 24, 2024 and Jul 13, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2026Material Split, Cut or Torn

  Patient problems: Foreign Body In Patient

  MAUDE report 25797855 ↗
• MalfunctionJul 13, 2026Material Split, Cut or Torn

  Patient problems: Foreign Body In Patient

  MAUDE report 25797636 ↗
• MalfunctionJan 15, 2026Break

  ON 30-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-2424PHS PEEK KNOTLESS HIP SUTURETAK SUTURE ANCHOR PULLED OUT OF BONE. THE SURGEON SUBSEQUENTLY REDRILLED AND ATTEMPTED TO INSERT ANOTHER AR-2424PHS PEEK KNOTLESS HIP SUTURETAK SUTURE ANCHOR, WHICH BROKE IN HALF DURING INSERTION. THE PROCEDURE WAS COMPLETED USING TWO KNOTLESS FIBERTAK ANCHORS AND ONE CINCHLOCK DEVICE. THIS WAS DISCOVERED DURING A HIP ARTHROSCOPY/PINCER PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS REQUESTED ON 02-JAN-2026.

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

  MAUDE report 24078557 ↗
• MalfunctionJan 15, 2026Break; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED ON 12-JAN-2026: ON INSERTION, BOTH AR-2424PHS PEEK KNOTLESS HIP SUTURETAK SUTURE ANCHOR IMPLANTS FRACTURED. THE IMPLANTS WERE REMOVED, AND ALL DETACHED FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING TWO AR-3636H SELF-PUNCHING 1.8 KNOTLESS HIP FIBERTAK SOFT ANCHORS AND ONE NON-ARTHREX IMPLANT. THE EVENT RESULTED IN AN ESTIMATED 5¿10-MINUTE DELAY TO REDRILL AND PASS SUTURE FOR THE FINAL ANCHOR, WITH ADDITIONAL ANESTHESIA ADMINISTERED DURING THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 24078488 ↗
• MalfunctionJan 15, 2025Device Damaged by Another Device; Device Damaged by Another Device

  ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2424PHS SUTURE ANCHOR HAD AN ISSUE DURING A HIP LABRAL REPAIR PROCEDURE ON (B)(6)2024. WHEN THE SURGEON IMPLANTED THE ANCHOR, ONE OF THE SUTURES COMING OUT OF IT HAD BEEN PIERCED THROUGH BY ANOTHER SUTURE, AND THE KNOTLESS MECHANISM DID NOT WORK. THE SURGEON REMOVED ALL SUTURES AND THE ANCHOR IN ONE PIECE FROM THE PATIENT. NOTHING BROKE INSIDE THE PATIENT, AND THERE WAS NO PATIENT HARM. ANOTHER AR-2424PHS SUTURE ANCHOR WITH THE SAME LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A SLIGHT CASE DELAY OF A COUPLE OF MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE COMPLAINT DEVICE WAS DISCARDED, AND NO PICTURES WERE TAKEN. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21157254 ↗
• MalfunctionDec 5, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY SALES REPRESENTATIVE VIA PHONE THAT THREE AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK AND AN AR-2424PHS PEEK, 2.4 MM KNOTLESS HIP SUTURETAK WHITE SHUTTLE SUTURE SNAPPED WHILE FLOSSING AND SHUTTLING THE SUTURES. SOME OF THE SUTURES WERE TIED TOGETHER AND AN AR-6955 HIP LABRAL RECONSTRUCTION IMPLANT SYSTEM WAS USED TO COMPLETE THE CASE. THE REMAINING SUTURES WERE CUT OUT AND REMOVED. THE CASE OVERALL LASTED TWO ADDITIONAL HOURS. THIS WAS DISCOVERED DURING A HIP LABRAL REPAIR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20857768 ↗
• MalfunctionOct 9, 2024Positioning Failure; Positioning Failure

  ON (B)(6) 2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT TWO AR-2424PHS PEEKS KNOTLESS HIP SUTURETAK ANCHORS FELL OFF THE INSERTER SHAFT BEFORE BEING INSERTED IN THE DRILLED BONE SOCKET. THE SURGEON COMPLETED THE CASE USING ANOTHER IMPLANT. THIS WAS DISCOVERED DURING A HIP LABRAL REPAIR PROCEDURE ON (B)(6) 2024. THE CASE WAS DELAYED LESS THAN FIFTEEN MINUTES; HOWEVER, ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 20406844 ↗
• MalfunctionOct 9, 2024Positioning Failure; Positioning Failure

  ON (B)(6) 2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT TWO AR-2424PHS PEEKS KNOTLESS HIP SUTURETAK ANCHORS FELL OFF THE INSERTER SHAFT BEFORE BEING INSERTED IN THE DRILLED BONE SOCKET. THE SURGEON COMPLETED THE CASE USING ANOTHER IMPLANT. THIS WAS DISCOVERED DURING A HIP LABRAL REPAIR PROCEDURE ON (B)(6) 2024. THE CASE WAS DELAYED LESS THAN FIFTEEN MINUTES; HOWEVER, ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 20406731 ↗
• MalfunctionSep 18, 2024Break; Break

  ON 9/5/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT TWO AR-2424PHS HIP SUTURETAK ANCHOR BODIES BROKE DURING INSERTION. THE BONE SOCKET WITH AN AR-2424DHC-1 DISPOSABLES KIT FOR 2.4 KNOTLESS HIP SUTURETAK. THE SURGEON FELT THE DRILL DID NOT PROPERLY DRILL THE CORRECT SIZE FOR THE SUTURETAK, THE HOLE WAS NOT LARGE ENOUGH. WHEN THE SUTURETAK ANCHORS WERE INSERTED, THEY BROKE. EVERYTHING WAS REMOVED FROM INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A HIP ARTHROSCOPY PROCEDURE ON (B)(6) 2024. THE CASE WAS NOT DELAYED. THE CASE WAS COMPLETED USING A 2.9 PUSHLOCK.

  Patient problems: Insufficient Information

  MAUDE report 20248224 ↗
• MalfunctionSep 18, 2024Break; Break

  ON 9/5/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT TWO AR-2424PHS HIP SUTURETAK ANCHOR BODIES BROKE DURING INSERTION. THE BONE SOCKET WITH AN AR-2424DHC-1 DISPOSABLES KIT FOR 2.4 KNOTLESS HIP SUTURETAK. THE SURGEON FELT THE DRILL DID NOT PROPERLY DRILL THE CORRECT SIZE FOR THE SUTURETAK, THE HOLE WAS NOT LARGE ENOUGH. WHEN THE SUTURETAK ANCHORS WERE INSERTED, THEY BROKE. EVERYTHING WAS REMOVED FROM INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A HIP ARTHROSCOPY PROCEDURE ON (B)(6) 2024. THE CASE WAS NOT DELAYED. THE CASE WAS COMPLETED USING A 2.9 PUSHLOCK.

  Patient problems: Insufficient Information

  MAUDE report 20248196 ↗
• MalfunctionAug 6, 2024Break; Break

  ON 07/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-2424PHS PEEK, 2.4 MM KNOTLESS HIP SUTURETAK ANCHORS BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19921517 ↗
• MalfunctionAug 6, 2024Break; Break

  ON 07/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-2424PHS PEEK, 2.4 MM KNOTLESS HIP SUTURETAK ANCHORS BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19921251 ↗
• MalfunctionApr 24, 2024Break; Break

  ON 03/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-2424PHS PEEK, 2.4 MM KNOTLESS HIP SUTURETAK BROKE DURING IMPLANTATION. ANCHORS WERE PLACED THROUGH A DALA PORTAL USING A STRAIGHT GUIDE FROM AR-2424DHS KNOTLESS HIP SUTURETAK DISPOSABLES KIT AND THE DRILL FROM AN AR-2424DF-19 1.9 MM FLEXIBLE FLUTED DRILL FOR 2.4 MM KNOTLESS HIP SUTURETAK. THE DRILL WAS CHUCKED UP 3MM SHY OF THE BLACK LASER LINE TO GIVE FURTHER BUFFER ROOM TO CLEAR BONE AND NOT HAVE THE ANCHOR BOTTOM OUT PREMATURELY FROM RESIDUAL LEFT BEHIND BONE. THE DRILL WAS CYCLED SEVEN TIMES. THE ANCHOR WAS IMPLANTED PER TECHNIQUE WITH FIRM HAND PRESSURE TO START THEN LIGHT MALLETS TO THE INSERTER. HOWEVER, THE ANCHORS BROKE. ALL PARTS OF THE IMPLANTS WERE RETRIEVED, AND NO HARM WAS CAUSED TO THE PATIENT. THE LABRAL REPAIR WAS COMPLETED BY IMPLANTING AN AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK IN A NEW HOLE SPACED RESPONSIBLY AWAY FROM THE PREVIOUSLY DRILL HOLE. THIS WAS DISCOVERED DURING A HIP ARTHROSCOPY LABRAL REPAIR PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173167 ↗
• MalfunctionApr 24, 2024Break; Break

  ON 03/28/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-2424PHS PEEK, 2.4 MM KNOTLESS HIP SUTURETAK BROKE DURING IMPLANTATION. ANCHORS WERE PLACED THROUGH A DALA PORTAL USING A STRAIGHT GUIDE FROM AR-2424DHS KNOTLESS HIP SUTURETAK DISPOSABLES KIT AND THE DRILL FROM AN AR-2424DF-19 1.9 MM FLEXIBLE FLUTED DRILL FOR 2.4 MM KNOTLESS HIP SUTURETAK. THE DRILL WAS CHUCKED UP 3MM SHY OF THE BLACK LASER LINE TO GIVE FURTHER BUFFER ROOM TO CLEAR BONE AND NOT HAVE THE ANCHOR BOTTOM OUT PREMATURELY FROM RESIDUAL LEFT BEHIND BONE. THE DRILL WAS CYCLED SEVEN TIMES. THE ANCHOR WAS IMPLANTED PER TECHNIQUE WITH FIRM HAND PRESSURE TO START THEN LIGHT MALLETS TO THE INSERTER. HOWEVER, THE ANCHORS BROKE. ALL PARTS OF THE IMPLANTS WERE RETRIEVED, AND NO HARM WAS CAUSED TO THE PATIENT. THE LABRAL REPAIR WAS COMPLETED BY IMPLANTING AN AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK IN A NEW HOLE SPACED RESPONSIBLY AWAY FROM THE PREVIOUSLY DRILL HOLE. THIS WAS DISCOVERED DURING A HIP ARTHROSCOPY LABRAL REPAIR PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19172683 ↗