Arthrex® AR-13325Recalls & reported problems
Arthrex, Inc. · RADIOLUCENT RETRACTOR, 38 DEG BLUNT TIP · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867011359), received between May 6, 2024 and Jun 17, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Device Damaged Prior to Use1
- Device Damaged by Another Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2024Break; Break
ON 05/16/2024, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-13325 RADIOLUCENT RETRACTOR BROKE OFF. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19547423 ↗MalfunctionMay 22, 2024Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT THE AR-13325 IS DAMAGED.
Patient problems: Insufficient Information
MAUDE report 19375497 ↗MalfunctionMay 6, 2024Device Damaged by Another Device; Device Damaged by Another Device
IT WAS REPORTED THAT THE LEVER SURFACE OF THE DEVICE WAS DESTROYED BY THE CUSTOMER WITH A SAW. THE SURFACE OF THE DEVICE HAS INDENTATIONS AND SCRATCHES AND CAN THEREFORE NO LONGER BE USED. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19255780 ↗
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- FIRSTPASS 72290128Smith & Nephew, Inc. · ACCESSORIES,ARTHROSCOPIC232 reports
- NA 251723Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC145 reports
- COBRA 3910900093Stryker Corporation · Accessories, arthroscopic138 reports
- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
- FirstPass 72290130Smith & Nephew, Inc. · Accessories, arthroscopic80 reports
- 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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