Arthrex® AR-1934PIRecalls & reported problems
Arthrex, Inc. · 2.4MM S-TAK PERC INSERT DISP KIT · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867024137), received between Jul 19, 2023 and Jun 5, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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
- Material Twisted/Bent1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2024Mechanical Jam; Mechanical Jam
ON 03/01/2022 IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT WHEN THE SURGEON MADE A PILOT HOLE USING THE AR-1934PI SUTURETAK 2.4MM DRILL ATTACHED TO THE POWER THROUGH THE DISPOSABLE DRILL GUIDE. THE DRILL WAS STUCK AND COULD NOT ROTATE ANY MORE. THIS WAS DISCOVERED DURING USE IN A PROCEDURE ON (B)(6) 2022. THE CASE WAS COMPLETED BY USING A NEW AR-01934PI.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19467985 ↗MalfunctionJul 19, 2023Material Twisted/Bent; Material Twisted/Bent
ON 06/20/2023, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA SEMS THAT AN AR-1934PI PERC INSERT KIT DRILL BIT BENT AND BECAME STUCK INSIDE THE GUIDE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17350853 ↗
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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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