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

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867298026), received between May 15, 2024 and Jun 10, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT (3) AR-3636H 1.8 KNOTLESS HIP FIBERTAKS, AND (2) AR-3600ND-2H DISPOSABLE DRILLS FAILED. THIS OCCURRED DURING AN ARTHROSCOPIC HIP LABRAL REPAIR ON (B)(6) 2023 WHEN DRILLING FOR THE ANCHORS IT FELT AS IF THE DEVICE WAS CHATTING UP AGAINST THE CURVED GUIDE. THE GUIDE WAS PULLED OUT OF THE HIP AND RAN THE DRILL THROUGH IT WITH THE SAME RESULT. THE DRILL GUIDE WAS SWITCHED OUT AND THE SAME ISSUE OCCURRED. AN ADDITIONAL DRILL BIT WAS TRIED AND THE ISSUE PERSISTED. A THIRD DRILL BIT WITH A DIFFERENT LOT NUMBER AND THE SAME DRILL GUIDE WAS TRIED AND THERE WAS NO CHATTER OF THE DRILL BIT. AFTER THE GUIDE AND DRILL BIT ISSUE WAS RESOLVED AND THEY BEGAN INSERTING THE ANCHORS, 3 OF THE ANCHORS PULLED OUT. THEY ALSO TRIED RELOADING EACH OF THESE ANCHORS AND REINSERTING AND THEY STILL PULLED OUT. IT WASN¿T UNTIL THEY OPENED AN ANCHOR OF A DIFFERENT LOT NUMBER THAT THE ANCHOR HELD IN THE BONE. THE PATIENT HAD AN UNUSUALLY HARD BONE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19497624 ↗
• MalfunctionMay 24, 2024Unintended Movement; Unintended Movement

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-06550600 THAT AN AR-3600ND-2H DISPOSABLE DRILL TIP SKIPS AFTER DRILLING. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 19393437 ↗
• MalfunctionMay 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 12/16/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT THREE AR-3602H ANCHORS PULLED OUT OF THE BONE DURING A HIP ARTHROSCOPY. THE FIRST ONE PULLED OUT OF THE BONE WHEN IT WAS SET. IT WAS REPLACED AND THE SAME EVENT OCCURRED. A THIRD ANCHOR WAS USED BUT ONCE AGAIN PULLED OUT. THE ANCHORS WERE REPLACED WITH A NON ARTHREX PRODUCTS AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE CASE INVOLVED A 32 YEAR OLD FEMALE AND, AS OF TODAY SHE IS FINE. THE REP IS ALSO RETURNING THE AR-3600ND-2H DRILL BIT TO BE INSPECTED ALSO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19380435 ↗
• MalfunctionMay 15, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DRILL WAS SHEARING BITS OFF IN THE REUSABLE SLEEVE. THE SURGEON OPENED A NEW AR-3600ND-2H WITHOUT FURTHER ISSUE. ADDITIONAL INFORMATION PROVIDED: PROCEDURE BEING PERFORMED WAS A LABRAL REPAIR. NO FRAGMENTS BROKE OFF. THE CASE WAS COMPLETED BY USING A DIFFERENT ANCHOR SYSTEM AR-1938BC.

  Patient problems: Insufficient Information

  MAUDE report 19319080 ↗