Arthrex® AR-3638DHC-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867430044), received between May 22, 2024 and Jan 26, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Material Fragmentation

  ON 30-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3638DHC-2 KNOTLESS HIP FTAK HAD METAL SHAVINGS COMING FROM THE DRILL. FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THIS WAS DISCOVERED DURING A HIP SCOPE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24180140 ↗
• MalfunctionDec 29, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3638DHC-2 DISP, CURVED KIT, KNOTLESS HIP FTAK DRILL TIP BROKE OFF IN THE ACETABULUM WHEN DRILLING FOR ANCHOR. THIS WAS DISCOVERED DURING A HIP LABRAL REPAIR.

  Patient problems: Insufficient Information

  MAUDE report 23905841 ↗
• MalfunctionAug 11, 2025Break; Break

  ON 07/24/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3638DHC-2 HIP FIBERTAK DRILL BIT TIP SNAPPED OFF IN THE PATIENT'S ACETABULUM. 15 MIN DELAY ON THE CASE. METAL WAS RETRIEVED. THIS OCCURRED DURING USE IN A CASE.

  Patient problems: Insufficient Information

  MAUDE report 22776252 ↗
• MalfunctionMay 14, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 04/28/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAK®SOFT ANCHOR SHUTTLING SUTURE BROKE. THIS OCCURRED DURING A HIP ARTHROSCOPY ON (B)(6) 2025, WHERE ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE PATIENT HAD A DENSE BONE QUALITY. A DRILL WAS USED TO PREPARE THE BONE. THEY CONTINUE WITH ANOTHER AR-363H THAT WORKED ACCORDINGLY. THERE WAS NO HARM TO THE PATIENT, OR DELAY IN THE PROCEDURE. THERE WAS ALSO AN AR-3638DHC-2 DISPOSABLES KIT DRILL GUIDE BENT; ANOTHER WAS OPENED AND WORKED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020641 ↗
• MalfunctionOct 17, 2024Break; Break

  ADDITIONAL INFORMATION WAS PROVIDED ON 10/03/2024 WHERE THE SALES REPRESENTATIVE STATED THAT THIS EVENT OCCURRED ON 10/26/2024 DURING A HIP LABRAL REPAIR, THE DRILL BIT BROKE WHILE DRILLING FOR THE 3RD ANCHOR IN THE REPAIR. THE SURGEON BELIEVES IT MAY HAVE SKIVED OFF THE ACETABULUM, BUT NEITHER THE SURGEON NOR PA FELT OR HEARD ANYTHING UNUSUAL WHILE DRILLING. THE PATIENT HAD HARD BONE PER THE SURGEON. AN AR-3638DHC-2; 1.9 DRILL BIT AND CURVED GUIDE WERE USED TO PREPARE THE BONE FOR INSERTION. THE BROKEN DRILL BIT FRAGMENT WAS EVENTUALLY FOUND IN SOFT TISSUE, ONCE THE BROKEN DRILL BIT FRAGMENT WAS REMOVED, THE SURGEON DID NOT PROCEED WITH RE-DRILLING AND INSERTING THE 3RD ANCHOR. THE CASE TOOK AN ADDITIONAL 2 HOURS TO FIND AND RETRIEVE THE DRILL BIT FRAGMENT WHICH REQUIRED ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 20472877 ↗
• MalfunctionJul 1, 2024Break; Break

  ON 6/3/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-06584113 THAT AN AR-3638DHC-2 DISPOSABLES KIT FOR KNOTLESS HIP FIBERTAK SUTURE ANCHOR 1.9 FLUTED DRILL BIT BROKE OFF INSIDE THE SOCKET WHEN DRILLING WITH THE 1.9-FLUTE DRILL AND ADVANCING INTO THE BONE. THE SURGEON WAS ABLE TO RETRIEVE THE DRILL BIT. THE CASE WAS COMPLETED WITH ANOTHER AR-3638DHC-2 DISPOSABLES KIT FOR KNOTLESS HIP FIBERTAK SUTURE ANCHOR. THIS WAS DISCOVERED DURING A HIP LABRAL REPAIR PROCEDURE ON (B)(6) 2024 WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 6/6/2024: THE CASE WAS DELAYED 10 MINUTES DUE TO RETRIEVING THE REST OF THE DRILL BIT. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT AND IT WAS STATED THAT THEY WERE UNSURE IF ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19642972 ↗
• MalfunctionMay 22, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-3638DHC DISPOSBALES KIT, FOR KNOTLESS HIP FIBERTAK® SUTURE ANCHOR, BROKE. THIS OCCURRED DURING A PROCEDURE ON (B)(6) 2024 WHEN THE DEVICE BROKE, THE PIECE WAS EMBEDDED IN BONE AND THEY HAD TO DIG TO GET IT OUT ADDING ABOUT 30 MINUTES TO THE CASE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED. ADDITIONAL INFORMATION RECEIVED ON 4/30/2024: THIS WAS DISCOVERED DURING A HIP LABRAL REPAIR PROCEDURE. THE DRILL BIT WAS USED IN THE PATIENT, AND IT BROKE. UNFORTUNATELY, IT WAS NOT NOTICED UNTIL THE X-RAY WAS TAKEN FOR THE CAM RESECTION. AT THE TIME OF THE DEVICE BREAKING, THERE WAS STILL MORE TO DO IN THE PROCEDURE; THE SALES REPRESENTATIVE WAS UNSURE HOW MUCH ANESTHESIA WAS ADMINISTERED. INITIALLY, PART NUMBER AR-3638DHC DISPOSABLES KIT WAS REPORTED AS THE FAULTY DEVICE; HOWEVER, THE SALES REPRESENTATIVE HAS REPORTED THAT THE CORRECT PART NUMBER IS AR-3638DHC-2 DISPOSABLES KIT. THE PROCEDURE WAS COMPLETED USING PRODUCTS FROM ANOTHER MANUFACTURER.

  Patient problems: Insufficient Information

  MAUDE report 19369841 ↗