Arthrex® AR-12040Recalls & reported problems
Arthrex, Inc. · PUNCH, WIDEBITER, 3.4 MM STRAIGHT · 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 00888867004016), received between Apr 28, 2022 and May 15, 2024 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2024Break; Break
IT WAS REPORTED THAT THE AR-12040 PUNCH BROKE DURING A PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19321399 ↗MalfunctionJan 24, 2024Break; Break
ON 28-DEC-2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A WIDEBITER PUNCH, AR-12040, SPLIT INTO TWO PIECES. OCCURRED DURING A CASE, NO ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18571124 ↗MalfunctionJul 12, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-12040 WIDEBITER PUNCH BROKE. THIS OCCURRED DURING A CASE.
Patient problems: Insufficient Information
MAUDE report 17304355 ↗MalfunctionApr 28, 2022Break
IT WAS REPORTED THAT THE AR-12040 HAS BROKEN TIPS. NO ADVERSE EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14239849 ↗
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- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
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- MITEK 242025Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC61 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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