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

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867298019), received between Feb 14, 2022 and Oct 23, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2024Break; Break

  ON (B)(6)2024, A DISTRIBUTOR VIA (B)(4) REPORTED THAT AN AR-3600D-2H DRILL FOR A HIP FIBERTAK SUTURE ANCHOR BROKE DURING USE. THIS ISSUE OCCURRED WHEN THE SURGEON PUT IN THE FIRST ANCHOR OF A LABRAL REPAIR. THE TRAJECTORY OF THE DRILL & GUIDE WAS GOOD; WHEN THE SURGEON DRILLED TO THE GUIDE'S HARD STOP, THE DRILL TIP BROKE OFF IN THE BONE. THE SURGEON WAS ABLE TO BURR AROUND THE DRILL BIT & USE A CHONDRAL PICK TO CREATE SPACE AROUND THE DRILL BIT. THE SURGEON THEN GRASPED THE END OF THE DRILL BIT WITH A KINGFISHER & REMOVED THE BROKEN PIECE AND CONFIRMED. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED, AND NO SECONDARY SURGERY WAS NEEDED. THIS WAS DISCOVERED DURING A HIP ARTHROSCOPY PROCEDURE WITH LABRAL REPAIR ON (B)(6)2024. ADDITIONAL INFORMATION WAS RECEIVED ON 10/08/2024: THERE WAS 8 MINUTES OF CASE DELAY WITH NO ADDED ANESTHESIA ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513483 ↗
• MalfunctionNov 29, 2023Break; Break

  ON 11/01/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3600D-2H DRILL BROKE. THIS OCCURRED DURING A HIP LABRAL REPAIR WHERE THE FRAGMENT WAS RETRIEVED AND THE CASE COMPLETED WITH NO FURTHER ISSUE.

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

  MAUDE report 18229317 ↗
• MalfunctionJul 3, 2023Break; Break

  ON 6/6/2023, IT WAS REPORTED BY A SALE REPRESENTATIVE VIA EMAIL THAT A HIP 1.8MM DRILL BROKE IN HALF. NO FURTHER INFORMATION HAS BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED ON 6/6/2023: AN AR-3600D-2H 1.8MM DRILL FOR HIP FIBERTAK BROKE DURING REAMING INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A LABRAL REPAIR PROCEDURE ON (B)(6) 2023. ALL THE BROKEN FRAGMENTS WERE RETRIEVED AND A NEW AR-3600D-2H 1.8MM DRILL FOR HIP FIBERTAK WAS USED TO COMPLETE THE CASE.

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

  MAUDE report 17246525 ↗
• MalfunctionFeb 13, 2023Break

  ON 01/25/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-3600D-2H DRILL, FOR HIP FIBERTAKS TIP BROKE OFF. THIS OCCURRED DURING A HIP SCOPE. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16361748 ↗
• MalfunctionFeb 13, 2023Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-3600D-2H DRILL, FOR HIP FIBERTAKS TIP BROKE OFF. THIS OCCURRED DURING A HIP SCOPE. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

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

  MAUDE report 16361721 ↗
• MalfunctionFeb 13, 2023Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-3600D-2H DRILL, FOR HIP FIBERTAKS TIP BROKE OFF. THIS OCCURRED DURING A HIP SCOPE. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16361706 ↗
• MalfunctionFeb 13, 2023Break; Difficult to Remove

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT A AR-3600D-2H DRILL, FOR HIP FIBERTAKS TIP BROKE OFF. THIS OCCURRED DURING A HIP SCOPE ON (B)(6) 2023. THE TIP WAS UNABLE TO RETRIEVED. THE CASE CONTINUED USING THE KNOTLESS FIBERTAKS.

  Patient problems: Foreign Body In Patient

  MAUDE report 16361700 ↗
• MalfunctionFeb 14, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3600D-2H DRILL BROKE ABOUT 20MM INTO THE PATIENTS ACETABULUM. THIS WAS DISCOVERED DURING A HIP SCOPE PROCEDURE. ADDITIONAL INFORMATION RECEIVED 1/27/2022: THIS WAS DISCOVERED DURING A LABRAL REPAIR PROCEDURE. AFTER THE DRILL BIT BROKE, SURGEON DID NOT REMOVE THE BROKEN FRAGMENTS AND IT STILL REMAINS IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 13526263 ↗