Arthrex® AR-6529-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867040021), received between Apr 30, 2024 and May 21, 2024 — classified as 3 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2024Unintended Movement; Unintended Movement

  THE HIP TRACTION BOOT CLAMP KEPT SLIPPING. THIS WAS NOTED AT THE START OF THE OPERATION BEFORE THE SURGEON SCRUBBED (DURING POSITIONING). THE PLASTIC CLAMP WAS CHANGED TO A NEW ONE. IT SLIPPED AGAIN (DURING POSITIONING) SO THE SURGEON TAPPED IT. THIS STOPPED IT FROM SLIPPING AGAIN. SLIGHT DELAY IN OPERATION DUE TO THIS BUT NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19366544 ↗
• MalfunctionApr 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-6529-06 TRACTION BOOT HAS AN ISSUE WITH THE RATCHETING STRAP. THE SLIDER IS POPPING OFF TRACK WHILE IN USE. NO PATIENT AFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19214982 ↗
• MalfunctionApr 30, 2024Break; Break

  ON 09/14/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAN AN AR-6529-06 BOOT IS BROKEN. THIS WAS DISCOVERED DURING USE WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212952 ↗