Arthrex® AR-11241XLRecalls & reported problems
Arthrex, Inc. · PUNCH WDBITRXL 15°UP 2.75MM15°CRVD SFT · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867003057), received between Aug 26, 2019 and Aug 26, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Component Missing” (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
- Component Missing1
- Dull, Blunt1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2019Component Missing; Dull, Blunt
THE DEVICE WAS RECEIVED BY ARTHREX (B)(4) FROM THE CUSTOMER WITH A NOTE THAT STATED ¿DULL¿. NO ADDITIONAL INFORMATION AS TO WHAT FAILURE MODE OCCURRED WAS PROVIDED. NO ADVERSE CONDITIONS REPORTED FOR PATIENT, OPERATOR OR THIRD PARTY. UPDATE 06-AUG-2019: THE DEVICE AR-11241XL WAS INVESTIGATED BY ARTHREX (B)(4). THE INVESTIGATION SHOWED THAT THE TIP OF THE DEVICE IS MISSING. ARTHREX (B)(4) CONTACTED THE CUSTOMER TO VERIFY IF THE BROKEN TIP WAS RETRIEVED FROM THE PATIENT OR IF THE BROKEN TIP REMAINED INSIDE THE PATIENT. IT WAS NOT POSSIBLE FOR THE CUSTOMER TO CONFIRM IF THE TIP WAS RETRIEVED OR NOT.
Patient problems: Foreign Body In Patient
MAUDE report 8930535 ↗
Other Accessories, arthroscopic devices
- Arthrex® AR-12990Arthrex, Inc. · Accessories, arthroscopic409 reports
- NA 228302Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC287 reports
- 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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