Arthrex® AR-3638DHC-1Recalls & reported problems
Arthrex, Inc. · Disp. Curved Kit Knotless Hip FTAK 1.8mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867430037), received between Jun 20, 2024 and May 1, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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.
Reports received per month
Most reported problems
Device problems
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2025Break; Break
ON 04/14/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3638DHC-1 DISP. CURVED KIT KNOTLESS HIP FTKA DRILL BIT BROKE OFF IN BONE. THE BROKEN FRAGMENT WAS RETRIEVED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21944958 ↗MalfunctionDec 12, 2024Break; Break
ON 11/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06711998 THAT AN AR-3638DHC-1 KNOTLESS FIBERTAK BROKE OFF INSIDE THE PATIENT. BROKEN PIECE WAS REMOVED. ANOTHER DEVICE WAS OPENED, AND IT TOO BROKE OFF INSIDE THE PATIENT. BROKEN PIECE WAS RETRIEVED FROM PATIENT. ANOTHER LOT NUMBER WAS USED, AND THE CASE WAS COMPLETED WITH NO ADVERSE EFFECTS TO THE PATIENT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20916575 ↗MalfunctionDec 12, 2024Break; Break
ON 11/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3638DHC-1 KNOTLESS FIBERTAK BROKE OFF INSIDE THE PATIENT. BROKEN PIECE WAS REMOVED. ANOTHER DEVICE WAS OPENED, AND IT TOO BROKE OFF INSIDE THE PATIENT. BROKEN PIECE WAS RETRIEVED FROM PATIENT. ANOTHER LOT NUMBER WAS USED, AND THE CASE WAS COMPLETED WITH NO ADVERSE EFFECTS TO THE PATIENT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20915617 ↗MalfunctionJun 20, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3638DHC-1 DISPOSABLES KIT 1.8 DRILL BIT BROKE OFF. THIS OCCURRED DURING USE AND THE DRILL BIT WAS RETRIEVED FROM THE PATIENT, A NEW KIT WAS USED WITH NO ISSUES, AND NO HARM TO THE PATIENT, AND SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19573644 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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