Arthrex® AR-3600ND-4HFRecalls & reported problems
Arthrex, Inc. · 1.9mm Flexible Drill Hip FTAK, Fluted · 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 00888867430020), received between Apr 4, 2025 and Sep 8, 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
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50669794 ↗MalfunctionDec 3, 2025Break; Break
ON 11/13/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4). THAT AN AR-3600ND-4HF 1.9MM FLEXIBLE DRILL HIP TIP BROKE OFF INSIDE THE PATIENT'S ACETABULUM WHILE THE BONE WAS BEING DRILLED. THIS WAS DISCOVERED DURING A HIP LABRAL REPAIR AND WAS COMPLETED WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704551 ↗MalfunctionApr 4, 2025Break; Break
ON 03/17/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (4) AR-3636H SELF BUNCHING 1.8 KNOTLESS HIP FIBERTAKS FAILED, AN AR-3600ND-4HF DISPOSABLE FLEXIBLE FLUTED DRILL BROKE, AND AN AR-6527-19 HOOK KNIFE BROKE. THIS OCCURRED DURING A HIP ARTHROSCOPY ON 03/14/2025 THE FIRST ANCHOR DID NOT HOLD IN THE BONE AND THE THE INSERTER WAS BENT. THE SECOND ONE BACKED OUT OF THE BONE, THE THIRD ONES SUTURE WAS FRAYED AND WAS NOT USED. THE FOURTH ONE WAS PLACED IN THE BONE AND THEN WHEN CONVERTING THE SUTURE THE TENSIONING BROKE. THE IMPLANT REMAINED IN THE PATIENT. THEY SWITCHED TO AN AR-3600ND-4HF DRILL WHICH BROKE. ALL FRAGMENTS WERE RETRIEVED. THEY PROCEEDED WITH STANDARD PUSHLOCKS. THE AR-6527-19 15244183 BENT AND BROKE. ALL FRAGMENTS WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21773529 ↗
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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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