Arthrex® AR-1789J-CPRecalls & reported problems
Arthrex, Inc. · IB Kit, Plus, BC, w/ CC FT and JumpStart · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867318144), received between Apr 8, 2024 and Jul 21, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED ON 7/2/2025: THIS WAS DISCOVERED DURING AN ARTHROSCOPY WITH OPEN MEDIAL COLLATERAL LIGAMENT REPAIR PROCEDURE. DURING THE PROCEDURE, THE BROKEN FRAGMENT WAS NOT REMOVED, NOR WAS IT ADDRESSED IN A SUBSEQUENT SURGERY.
Patient problems: Foreign Body In Patient
MAUDE report 22555589 ↗MalfunctionApr 8, 2024Break; Break
ON 3/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE K-WIRE FROM AN AR-1789J-CP INTERNALBRACE IMPLANT SYSTEM SNAPPED OFF IN THE PATIENT. THE SURGEON WAS UNABLE TO RETRIEVE THE BROKEN FRAGMENTS. THE SUFFERED NO NEGATIVE EFFECT, AND THE CASE WAS COMPLETED. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 3/27/2024: THIS WAS DISCOVERED DURING A LATERAL ANKLE STABILIZATION PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING AN AR-8991CP DX KNOTLESS FIBERTAK IMPLANT KIT. THE CASE WAS DELAYED BETWEEN THIRTY TO FORTY-FIVE MINUTES AND ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 19060638 ↗
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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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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