Arthrex® AR-15310WRecalls & reported problems
Arthrex, Inc. · PUNCH,MED 3.4 MM15°UP CRVD,220MM W/WB · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867018686), received between Feb 21, 2022 and Feb 21, 2022 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2022Break
ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-15310W PUNCH, BROKEN DURING A CASE, PATIENT WAS NOT AFFECTED. ADDITIONAL INFORMATION 02/09/2022: ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT WHEN THE SURGEON WAS USING THE AR-15310W PUNCH ON THE LABRUM, IT BROKE. THE INSTRUMENT BROKE IN THE PATIENT BUT IT LOOKS TO BE AN INTERNAL BREAKAGE OF THE WISH BONE AREA OF THE HANDLE. NOTHING WAS LEFT IN THE PATIENT. THIS WAS DISCOVERED DURING USE IN A LARGE CALCIFIED HIP LABRUM TEAR ON (B)(6) 2022. THE CASE WAS COMPLETED BY USING THE SHAVER AND BANANA BLADE TO FINISH THE RESECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13569731 ↗
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- NA 228302Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC287 reports
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- 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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