Arthrex® AR-613-45Recalls & reported problems
Arthrex, Inc. · iBALANCE TKA, IM ROD, MODULAR · Class 1
Data updated Oct 16, 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 00888867116467), received between Dec 20, 2023 and May 23, 2024 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2024Break; Break
ON 5/23/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-613-48 MODULAR T-HANDLE BROKE WHEN SURGEON WAS ASSEMBLING IT TO AN AR-613-45 IM ROD. NOTHING BROKE INSIDE THE PATIENT AND CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER SET. THIS WAS DISCOVERED DURING A TKA PROCEDURE ON (B)(6) 2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19386097 ↗MalfunctionDec 20, 2023Break; Break
ON 11/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4), THAT AN AR-613-48 MODULAR T-HANDLE WAS USED AND BROKE THE TIP OFF OF AN AR-613-45 IM ROD. THIS OCCURRED DURING USE IN A TOTAL KNEE ARTHROPLASTY PROCEDURE ON 11/20/2023 WHERE NOTHING BROKE OFF INSIDE THE PATIENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18362533 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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