Arthrex® AR-7534Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867288829), received between Jun 21, 2021 and Feb 11, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Device Dislodged or Dislocated

  ON 22-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-7534 FIBERLOOP 1.3 MM SUTURE TAPE SUTURES BECAME UNSWAGED AT THE SUTURE JUNCTION. THIS DID NOT IMPACT THE OUTCOME OF THE CASE, AS AN AR-7534 FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026.

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

  MAUDE report 24313255 ↗
• MalfunctionFeb 11, 2026Device Dislodged or Dislocated

  ON 22-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-7534 FIBERLOOP 1.3 MM SUTURE TAPE SUTURES BECAME UNSWAGED AT THE SUTURE JUNCTION. THIS DID NOT IMPACT THE OUTCOME OF THE CASE, AS AN AR-7534 FROM A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026.

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

  MAUDE report 24313254 ↗
• MalfunctionJul 7, 2025Break; Break

  ON 06/10/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (2) AR-7534 FIBERLOOP® 1.3MM SUTURE TAPE SUTURES BROKE ON BOTH. THIS OCCURRED DURING A DISTAL BICEPS REPAIR ON (B)(6) 2025. THE SUTURE BROKE. ALL FRAGMENTS OF THE SUTURES WERE RETRIEVED. ONE OF THE BUTTONS REMAINED IN PLACE, AND THE OTHER BUTTON REMAINED IN THE CANAL. THERE WAS A DELAY OF ABOUT 20 MINUTES TO GET A NEW KIT AND REDO EVERYTHING; IT IS UNCERTAIN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414217 ↗
• MalfunctionJul 7, 2025Break; Break

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (2) AR-7534 FIBERLOOP® 1.3MM SUTURE TAPE SUTURES BROKE ON BOTH. THIS OCCURRED DURING A DISTAL BICEPS REPAIR ON (B)(6) 2025. THE SUTURE BROKE. ALL FRAGMENTS OF THE SUTURES WERE RETRIEVED. ONE OF THE BUTTONS REMAINED IN PLACE, AND THE OTHER BUTTON REMAINED IN THE CANAL. THERE WAS A DELAY OF ABOUT 20 MINUTES TO GET A NEW KIT AND REDO EVERYTHING; IT IS UNCERTAIN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414080 ↗
• MalfunctionMay 1, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 5/1/2025: THIS ISSUE OCCURRED WHILE IT WAS INSIDE THE PATIENT. ALL THE BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 21942385 ↗
• MalfunctionAug 18, 2022Break

  DURING A ACLR SURGERY, ON THE FIRST INSTANCE THE SUTURE SNAPPED WHEN THE SURGEON ATTEMPTED TO TIE OFF THE SUTURES OVER THE TIBIAL BUTTON. ON THE SECOND INSTANCE HE WAS WHIP STITCHING THE HAMSTRING GRAFT AND SUTURE SNAPPED WITH LITTLE TO NO TENSION. THESE TWO INSTANCES HAPPENED WITHIN THE SPACE OF 2 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15249481 ↗
• MalfunctionAug 17, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA EMAIL THAT A AR-7534 FIBERLOOP WAS USED IN AN UNKNOWN CASE WHILE GRAFT SUTURING THE TAPE BROKE AFTER THE FIRST STITCH. A NEW PRODUCT WAS USED TO COMPLETE THE CASE, AND THERE WAS NO PATIENT EFFECT REPORTED. NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15242847 ↗
• MalfunctionMar 7, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-7534 FIBERLOOP SUTURETAPE NEEDLE LOOP BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. A NEW PRODUCT WAS USED AND CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: THIS WAS DISCOVERED DURING A PCL REPAIR AND ALL BROKEN FRAGMENTS WERE REMOVED FROM INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13684767 ↗
• MalfunctionJun 21, 2021Break

  IT WAS REPORTED, DURING AN ELBOW DISTAL BICEP PROCEDURE, THE SURGEON WAS USING THE AR-1676ST, GRAFT SIZING KIT. AFTER INSERTION OF THE AR-7534, SUTURE TAPE FIBERLOOP, THE WHIP STITCH FLIPPED THE BUTTON, THE SURGEON WENT TO HAND TIGHTEN THE SUTURE AND THE FIBERLOOP BROKE AT. THE CASE WAS COMPLETED LEAVING ONE TAIL SHORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032423 ↗