Arthrex® AR-613-48Recalls & reported problems
Arthrex, Inc. · iBALANCE TKA, MODULAR T-HANDLE · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867116498), received between Apr 13, 2021 and Dec 6, 2024 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break5
- Crack2
- Device Damaged by Another Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information2
- Failure of Implant1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 6, 2024Break; Break
ON 11/08/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-613-48 IBALANCE¿ TKA, MODULAR T-HANDLE BROKE IN HALF. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A KNEE PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20864179 ↗MalfunctionMay 23, 2024Break; Break
ON 09/29/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-613-48 HANDLE, AND A AR-613-1 HANDLE BROKE. THIS OCCURRED DURING AN UNKNOWN CASE WITH NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19387635 ↗MalfunctionDec 6, 2022Break
IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-48 T-HANDLE WAS HIT WITH A MALLET AND BROKE INTO PIECES. CASE INVOLVEMENT, NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15922885 ↗MalfunctionJul 5, 2022Crack
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-613-48 T-HANDLE CRACKED IN HALF. THIS OCCURRED DURING A TKA PROCEDURE, ALL FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED, WITH NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14915134 ↗MalfunctionJun 20, 2022Break
ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-48 T-HANDLE BROKE IN HALF WHEN SURGEON ATTEMPTED TO REMOVED THE IM ROD. THIS WAS DISCOVERED DURING A TKA PROCEDURE ON (B)(6) 2021. CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES.
Patient problems: Insufficient Information
MAUDE report 14743877 ↗MalfunctionJun 14, 2021Crack; Device Damaged by Another Device
IT WAS REPORTED DURING AN TKA PROCEDURE THE AR-613-48, T-HANDLE CRACKED IN HALF AFTER, THE SURGEON STRUCK IT WITH A MALLET. THE HOSPITAL DISCARDED THE TOOL.
Patient problems: Insufficient Information
MAUDE report 11991347 ↗MalfunctionApr 13, 2021Break
IT WAS REPORTED THAT THE AR-613-48 IS SHATTERED.
Patient problems: Failure of Implant
MAUDE report 11655714 ↗
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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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