Arthrex® AR-3600ND-2Recalls & reported problems
Arthrex, Inc. · 1.8MM DRILL FOR FIBERTAK · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867101982), received between Jun 7, 2024 and Jun 7, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 09/30/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT WHILE THE SURGEON WAS PERFORMING A LABRAL REPAIR ON (B)(6) 2021, QUANTITY 6 OF AN AR-3638, LOT: 13255279, PULL OUT AT VARIOUS POINTS DURING THE IMPLANTING/TENSION PROCESS. THE SURGEON ALSO USED THE REUSABLE CURVED GUIDE WITH THE 1.8MM DRILL, AR-3600ND-2, LOT: 12691838, CYCLING MULTIPLE TIMES AS RECOMMENDED AND PULLING BACK TO SET THE ANCHOR. THE CASE WAS COMPLETED BY DRILLING NEW SPOTS AND PLACING NEW AR-3638 FROM A DIFFERENT LOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19484528 ↗
Other BIT, DRILL devices
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- 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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