Arthrex® ABS-2001-OTRecalls & reported problems
Arthrex, Inc. · IOBP KNEE OPEN TIP PROCEDURE KIT · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867338531), received between Sep 28, 2021 and Jan 28, 2025 — classified as 1 injury, 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Fragmentation1
- Patient Device Interaction Problem1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2025Material Fragmentation; Patient Device Interaction Problem; Material Fragmentation; Patient Device Interaction Problem
IT WAS REPORTED THAT AFTER PROCEDURE, THE IMAGES OF MRI SHOWED BRIGHTNESS ON THE DECOMPRESSION SITE. THE PART WAS NOT VISIBLE IN THE RX IMAGES. THE PATIENT FELT PAIN AFTER THE SURGERY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO CLEAN THE DECOMPRESSION AREA. A SMALL PIECE OF INTRAOSSEOUS METAL WAS SEEN. THE SURGEON SUGGESTED IT WAS A PART OF THE DECOMPRESSION DEVICE THAT STAYED THERE.
Patient problems: Foreign Body In Patient; Pain
MAUDE report 21252019 ↗MalfunctionSep 28, 2021Break
ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN ABS-2001-OT IOBP CORE DECOMPRESSION DELIVERY KIT HAD THE CUTTING MECHANISM BREAK OFF INSIDE THE PATIENT. THIS OCCURRED DURING USE IN A IOBP PROCEDURE PERFORMED ON (B)(6) 2021. THE FRAGMENT WAS REMOVED FROM THE PATIENT, AND THE CASE WAS COMPLETED USING A SECOND KIT.
Patient problems: Insufficient Information
MAUDE report 12540212 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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