Arthrex® AR-6526SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867039865), received between Nov 2, 2020 and May 15, 2024 — classified as 1 injury, 2 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. How this data works · Data updated Oct 13, 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 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED DURING A HIP ARTHROSCOPY PROCEDURE THE SURGEON WAS USING THE AR-6526S HIP ARTHROSCOPY MASTER DISPOSABLE KIT WITH BLADES. THE SURGEON INSERTED THE NITINOL WIRES AND PLACED THE NEEDLE OVER TOP THE WIRES AND, WHILE PULLING OUT THE INSTRUMENTATION, THE WIRES WOULD COME OUT AS WELL. THE SURGEON INFORMED THE REP THAT THEY BELIEVE THE NITINOL WIRES ARE TOO LARGE FOR THE PERCANEOUS NEEDLES. THE ISSUE WITH THE DEVICE DID NOT HINDER THE CASE AND THE PROCEDURE WAS COMPLETED AS PLANNED WITHOUT CAUSING HARM OR INJURY TO THE PATIENT. THERE ARE NO AVAILABLE PICTURES OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19321122 ↗
• MalfunctionJul 13, 2023Dull, Blunt; Dull, Blunt

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT TWO AR-6526S KITS CONTAINED DULL SHEPHERD HOOK BLADES. IT WAS INVOLVED IN A CASE. PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315475 ↗
• InjuryNov 2, 2020Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A SURGERY A NITINOL WIRE BROKE OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE 30-OCT-2020: FURTHER INFORMATION WERE PROVIDED THAT THE NITINOL WIRE BROKE OFF INSIDE THE PATIENT DURING A HIP ARTHROSCOPY AND IT REMAINED INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10771363 ↗