Arthrex® AR-3600D-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867101920), received between Sep 25, 2019 and Jun 4, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-06886193 THAT AN AR-3600D-3 DRILL WAS INSERTED INTO THE AR-3600D AND STARTED DRILLING, IT GOT STUCK IN THE MIDDLE AND WHEN TRIED TO FORCE IT OUT, THE DRILL BROKE. THIS CASE WAS COMPLETED BY USING ANOTHER PRODUCT OF SAME PRODUCT NUMBER. NO PATIENT HARMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22144518 ↗
• MalfunctionSep 13, 2024Break; Break

  IT WAS REPORTED THAT DURING AN INSTABILITY SURGERY OF THE SHOULDER THE DRILL BROKE OFF. IT WAS NOT NOTED AND THE PART REMAINED INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. NO FURTHER INFORMATION RECEIVED. UPDATE DW 04-SEP-2024: FURTHER INFORMATION WAS PROVIDED THAT THE LOT NUMBER OF THE DEVICE WAS FOUND TO BE 022223. IT WAS FURTHER REPORTED THAT NO ADDITIONAL SURGERY AS IT WAS CONFIRMED ON THE CT THAT THE PART IS EMBEDDED IN THE BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20217556 ↗
• MalfunctionMay 24, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ELBOW STABILIZATION SURGERY WITH A FIBERTAK THE DRILL GOT JAMMED INSIDE THE SETTING TOOL WITHOUT A NOTICEABLE REASON. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391146 ↗
• InjurySep 25, 2019Break

  IT WAS REPORTED THAT A 1.70MM DRILL FOR FIBERTAK, AR-3600D-3, WAS BEING USED DURING AN ARTHROSCOPIC BANKART REPAIR. THE SURGEON MADE THREE BONE HOLES AND DEPLOYED FIBER TAK ANCHORS IN EACH HOLE WITH NO ISSUE. WHEN THE SURGEON WAS DRILLING THE FOURTH BONE HOLE, THE DRILL TIP BROKE AND THE BROKEN PIECE BECAME STUCK IN THE GLENOID. THE SURGEON TRIED TO RETRIEVE THE BROKEN PIECE BUT COULD NOT. THE SURGICAL SITE WAS CLOSED AND THE SURGERY WAS COMPLETED. ADDITIONAL INFORMATION PROVIDED 9/24/2019: THE REP CONFIRMED THAT TIP OF THE DRILL BIT WAS SECURED WITHIN THE BONE. NO SPECIAL MEASURE WAS TAKEN, BUT IT BITES HARD INTO THE BONES AND THE SURGEON DETERMINED THAT IT WOULD NOT MOVE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9118754 ↗