Arthrex® AR-3600D-1Recalls & reported problems
Arthrex, Inc. · 1.60MM DRILL FOR FIBERTAK · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867101906), received between Jun 21, 2021 and Sep 23, 2026 — classified as 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.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- Foreign Body In Patient2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Break
It was reported that during the surgery, the tip of the drill broke off and remained inside the patient´s bone. The broken piece is located under the anchor in the bone. This was discovered during the computer tomography after the surgery. No further information was received.*** Update 15-Sep-2026 - Further information was received:The incident occurred during the shoulder surgery. The broken-off piece is intended to remain in the patient permanently and the broken piece is firmly embedded in the bone because it is secured by the anchor. The surgery was finished successfully without using a different device. It was not necessary to switch the surgical technique. No second surgery was performed, and no revision surgery is planned. The patient underwent one postoperative computer tomography scan of the shoulder.
Patient problems: Foreign Body In Patient
MAUDE report 50867635 ↗MalfunctionApr 11, 2023Break; Break
ON 03/15/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3600D-1 DRILL BROKE. THIS OCCURRED DURING A LABRAL REPAIR ON (B)(6) 2023, WHEN HE WAS DRILLING INTO THE GLENOID THE END OF THE DRILL BIT BROKE OFF AND WAS STUCK IN THE GLENOID. THE PIECE OF THE DRILL WAS COUNTERSUNK INTO BONE SO IT HAD TO BE LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 16717569 ↗MalfunctionJun 21, 2021Break
IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY REPAIR, WHEN THE SURGEON INSERTED THE DRILL BIT TO MAKE THE TUNNEL AND ENTER THE ANCHOR AND THE TIP BROKE. THE FRAGMENT WAS RETRIEVED AND THE CASE WAS COMPLETED BY USING A NEW AR-3600D-1.
Patient problems: Insufficient Information
MAUDE report 12032479 ↗
Other BIT, DRILL devices
- QUICKSET 2274-25-500Depuy Orthopaedics, Inc. · BIT, DRILL1,985 reports
- QUICKSET 2274-35-500Depuy Orthopaedics, Inc. · BIT, DRILL770 reports
- QUICKSET 2274-30-500Depuy Orthopaedics, Inc. · BIT, DRILL761 reports
- NA 03.037.022Synthes GmbH · BIT, DRILL339 reports
- NA 323.062Synthes GmbH · BIT, DRILL309 reports
- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
- QUICKSET 2274-45-500Depuy Orthopaedics, Inc. · BIT, DRILL211 reports
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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