Arthrex® AR-6527-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867039872), received between Mar 22, 2017 and Jul 18, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE DEVICE GOT JAMMED, THE BUTTON TO PUSH/RETRACT THE KNIFE DIDN'T WORK. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542676 ↗
• MalfunctionMay 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGERY AFTER REMOVING THE RED PART AND SLIDING THE BLACK PART FORWARD IN ORDER TO SLIDE THE KNIFE OUT, THE BLACK PART CAME LOOSE AND FELL OFF. THE SURGEON THEN TRIED AGAIN WITH ANOTHER DEVICE WITH THE SAME BATCH FROM THE SAME BOX AND THE SAME THING HAPPENED AGAIN. THE SURGEON THEN USED A SHAVERBLADE (AR-6420CEX) TO COMPLETE THE PROCEDURE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19377193 ↗
• MalfunctionMay 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGERY AFTER REMOVING THE RED PART AND SLIDING THE BLACK PART FORWARD IN ORDER TO SLIDE THE KNIFE OUT, THE BLACK PART CAME LOOSE AND FELL OFF. THE SURGEON THEN TRIED AGAIN WITH ANOTHER DEVICE WITH THE SAME BATCH FROM THE SAME BOX AND THE SAME THING HAPPENED AGAIN. THE SURGEON THEN USED A SHAVERBLADE (AR-6420CEX) TO COMPLETE THE PROCEDURE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19369939 ↗
• MalfunctionApr 26, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING HIP ARTHROSCOPY SURGERY THE NITINOL WILL NOT GO THROUGH THE TIP OF THE RETRACTABLE CANNULATED KNIFE, STRAIGHT. THEY OPENED TWO KNIFES AND BOTH HAD THE SAME ISSUES. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. NO FURTHER INFORMATION RECEIVED. UPDATE, 25-MAR-2021 -SAC THE SURGERY HAS BEEN FINISHED SUCCESSFULLY WITH THE SAME DEVICE, DIFFERENT BATCH NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19195605 ↗
• MalfunctionApr 4, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 03/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-6527-01 RETRACTABLE CANNULATED KNIFE HANDLES COULD NOT SLIDE EVEN WITH PUSHING IN THE HANDLE. THIS WAS DISCOVERED DURING A PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19041381 ↗
• MalfunctionMar 26, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 03/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-6527-01 RETRACTABLE CANNULATED KNIFE HANDLES COULD NOT SLIDE EVEN WITH PUSHING IN THE HANDLE. THIS WAS DISCOVERED DURING A PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 18981716 ↗
• MalfunctionFeb 23, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE DEVICE DID NOT FLIP AND THEREFORE DID NOT WORK. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773440 ↗
• MalfunctionFeb 9, 2024Defective Device; Physical Resistance/Sticking; Defective Device; Physical Resistance/Sticking

  ON 25TH JANUARY 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT FOR AN AR-6527-01, RETRACTABLE CANNULATED KNIFE, STRAIGHT, THE BLADE ON THE CANNULATED RETRACTABLE KNIFE WOULD NOT DEPLOY. THIS WAS DETECTED DURING USE IN A HIP ARTHROSCOPY AND LABRAL REPAIR PROCEDURE ON (B)(6) 2024. PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER BLADE WAS OPENED WHICH WORKED CORRECTLY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18677709 ↗
• MalfunctionJan 25, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 01/3/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A RETRACTABLE KNIFE BLADE, AR-6527-01, WAS BEING USED IN A CASE AND, AFTER DEPLOYING AND BEING USED, IT RETRACTS BUT THEN WON'T COME BACK OUT OF THE SLOT FOR FURTHER USE. THIS OCCURRED DURING A CASE WITH NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18579323 ↗
• MalfunctionNov 28, 2023Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY THE BUTTON ON THE RETRACTABLE KNIFE BROKE OFF. THE SURGEON TRIED TO PUT THE BUTTON BACK ON THE HANDLE AND THEN THE WHOLE BLACK PART OF THE BLACK BUTTON BROKE OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220839 ↗
• InjuryMar 22, 2017Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, LABRAL REPAIR AND CAM LESION DEBRIDEMENT, THE SURGEON CUT THE HIP LABRAL AND DEPLOYED THE KNIFE WHICH BROKE IN THE PATIENT DURING CUTTING. THIS HAPPENED TWICE WITH TWO DEVICES FROM THE SAME LOT. THESE WERE BOTH RETRIEVED; THE CASE WAS NOT COMPLETED. THIS WAS DUE TO 45 MINUTES OF TRACTION TIME AND EXTRAVASATION IN THE ABDOMEN. THE SURGERY HAS BEEN RESCHEDULED IN 30 DAYS. PATIENT IS FEMALE IN HER 20S. ADDITIONAL INFORMATION OBTAINED 3/16/17: IT WAS REPORTED THAT PATIENT WAS NOT KEPT OVERNIGHT AND WAS DISCHARGED SAME DAY. EXTRAVASATION WAS RELIEVED WITH MASSAGE. SURGERY HAS BEEN RESCHEDULED FOR MONDAY, (B)(6).

  Patient problems: Extravasation

  MAUDE report 6423726 ↗