Arthrex® AR-613-65Recalls & reported problems
Arthrex, Inc. · iBALANCE TKA, DUAL SPIKE PUNCH · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867116733), received between May 18, 2021 and May 23, 2024 — classified as 3 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
- Material Twisted/Bent1
Patient problems
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2024Material Twisted/Bent; Material Twisted/Bent
ON (B)(6) 2022, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT A AR-613-65 DUAL SPIKE PUNCH IS BECOMING BENT WHERE THE SPIKES ATTACH TO THE BASE. THIS WAS DISCOVERED DURING AN UNKNOWN TIME, WITH NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19387755 ↗MalfunctionMar 8, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-65 DUAL SPIKE PUNCH PEG BROKE OFF AND AN AR-613-1 HANDLE WON'T ENGAGE PROPERLY. THIS WAS DISCOVERED DURING A PROCEDURE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 16501116 ↗MalfunctionMay 18, 2021Break
IT WAS REPORTED THAT THE AR-613-65 BROKE DURING INSERTION DURING A TKA PROCEDURE. THE REP REPORTED THE DEVICE DID NOT BREAK INTO DISCRETE PIECES. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER TRAY.
Patient problems: Insufficient Information
MAUDE report 11841215 ↗
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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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