Arthrex® AR-3600D-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867101913), received between Sep 6, 2022 and Mar 19, 2025 — classified as 10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2025Break; Break

  ON (B)(6)2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-3600D-2 DRILL BROKE OFF. THE BROKEN DRILL WAS REMOVED AND THE BONE HOLE RE-DRILLED IN ANOTHER LOCATION WITH ANOTHER PRODUCT. NO PATIENT HARMS. ADDITIONAL INFORMATION REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642984 ↗
• MalfunctionFeb 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY SURGERY THE TIP OF THE DEVICE BROKE. THE FRAGMENT REMAINED INSIDE THE GLENOID. 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 21322861 ↗
• MalfunctionJun 11, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 05/04/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3600D-2 DRILL GOT STUCK IN THE AR-3610ST SPEAR SLEEVE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19513051 ↗
• MalfunctionJun 10, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 05/18/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3600D-2 DRILL GOT BOUND UP IN THE AR-3610ST DRILL SLEEVE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505286 ↗
• MalfunctionMay 27, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED ON (B)(6) 2022 A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3610F STRAIGHT SPEAR WELDED ITSELF TO THE DRILL BIT AR-3600D-2. THIS WAS DISCOVERED DURING AFTER A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400138 ↗
• MalfunctionFeb 5, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-3638 KNOTLESS FIBERTAK ANCHOR BROKE DURING INSERTION. THE SURGEON RECOVERED ALL OF THE ANCHORS AND USED THE SUTURES FROM IT TO INSERT A 2.9 MM PUSHLOCK. ANOTHER AR-3638 KNOTLESS FIBERTAK WAS ATTEMPTED TO BE IMPLANTED, BUT IT ALSO BROKE DURING INSERTION. ALL THE FRAGMENTS WERE RECOVERED. THEN, THE SURGEON NOTICED THAT THE AR-3600D-2 1.8 MM DRILL USED TO PREPARE THE BONE HAD BROKEN BEFORE THE FIRST ANCHOR HAD BROKEN AND HAD NOT DRILLED THE APPROPRIATE DEPTH. THE BROKEN DRILL FRAGMENT WAS NOT RETRIEVED, THE SURGEON WAS CONFIDENT THAT IT STAYED BURIED IN THE BONE. THE DRILL WAS MEASURED, AND ABOUT 1.5 CM BROKE OFF. THE CASE WAS COMPLETED SUCCESSFULLY USING A NEW DRILL AND A NEW FIBERTAK. THIS WAS DISCOVERED DURING A LABRAL REPAIR PROCEDURE ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 18640853 ↗
• MalfunctionJul 10, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3600D-2 DRILL BIT BROKE OFF. IT WAS NOTICED WHEN THE ANCHOR WAS BEING SEATED THAT THE DRILL BIT BROKE. THE ANCHOR FIXATION HELD, AND THE LABRUM WAS SECURED. THE CASE WAS COMPLETED SUCCESSFULLY. THE BROKEN DRILL BIT WAS NOT RETRIEVED FROM INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A LEFT SHOULDER ARTHROSCOPY AND LABRUM REPAIR PROCEDURE ON (B)(6) 2023.

  Patient problems: Foreign Body In Patient

  MAUDE report 17286385 ↗
• MalfunctionJun 20, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION SURGERY THE DRILL BECAME STUCK IN THE DRILL GUIDE AND BROKE OFF. ALL BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. AS THE HOLE WAS ALREADY DRILLED SUCCESSFULLY NO ADDITIONAL DEVICE WAS NEEDED TO FINISH THE SURGERY SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164852 ↗
• MalfunctionDec 12, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A ARTHREX EMPLOYEE VIA SEMS THAT AN AR-3600D-2 DRILL FOR FIBERTAK BROKE DURING USE. CASE INVOLVEMENT, DEVICE BROKE DURING USE. ADDITIONAL INFORMATION REQUESTED (B)(6) 2022. RESPONSE:(B)(6) 20/22 STATED THAT DRILL BIT BROKE INSIDE THE PATIENT, ALL FRAGMENTS RETRIEVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959143 ↗
• MalfunctionSep 6, 2022Break; Use of Device Problem; Physical Resistance/Sticking

  ON 08/17/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT A AR-3600D-2 DRILL FOR FIBERTAK STOPPED, BROKE, AND WAS STUCK INTO THE GUIDE. THIS OCCURRED DURING THE REPAIR OF THE LABRUM CASE WHILE DRILLING RESISTANCE WAS FELT AND THE DRILL STOPPED, BROKE, AND WAS STUCK INTO THE GUIDE, IT WAS REALIZED THEN THAT A RIGID DRILL WAS PICKED AND NEEDED TO BE REPLACED WITH A FLEXIBLE DRILL TO BE USED WITH THE REUSABLE CURVED GUIDE. THE BROKEN FRAGMENT WAS RETRIEVED, AND THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362472 ↗