Arthrex® AR-3515HRecalls & reported problems
Arthrex, Inc. · DRILL SLEEVE, AVN · Class 1
Data updated Oct 16, 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 00888867253230), received between Oct 21, 2021 and Aug 8, 2022 — classified as 4 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
Device problems
- Break3
- Material Twisted/Bent1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2022Material Twisted/Bent
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3515H DRILL SLEEVE HAD AN ISSUE, THE TIP OF THE SHEATH BENT WHENEVER IT TOUCHED THE BONE. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15183150 ↗MalfunctionJun 27, 2022Break
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3515H DRILL SLEEVE BROKE. THIS WAS DISCOVERED DURING A PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 14828759 ↗MalfunctionMay 16, 2022Break
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT QTY.2 OF AN AR-3515H DRILL SLEEVE CONTAINED IN AVN/OCD TRAY SET HAS BROKEN. THIS ISSUE HAS OCCURRED AFTER ALMOST EVERY CASE. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14407122 ↗MalfunctionOct 21, 2021Break
ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3515H DRILL SLEEVE TIP BROKE OFF. THIS WAS DISCOVERED DURING A PROCEDURE. SURGEON RECOVERED TIP FROM PATIENT, NOTHING WAS LEFT INSIDE.
Patient problems: Insufficient Information
MAUDE report 12674488 ↗
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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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