Arthrex® AR-1593Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867258686), received between May 16, 2024 and May 26, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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.

• MalfunctionMay 26, 2026Break

  IT WAS REPORTED THAT DURING THE ANTERIOR CRUCIATE LIGAMENT SURGERY, THE ANCHOR BROKE OFF DURING INSERTION. A FRAGMENT OF THE BROKEN ANCHOR REMAINED INSIDE THE PATIENT'S BODY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION WAS RECEIVED. UPDATE 18-MAY-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING THE REFIXATION OF THE ANTERIOR CRUCIATE LIGAMENT, THE BIOCOMPOSITE SWIVELOCK ANCHOR BROKE OFF DURING INSERTION. A FRAGMENT OF THE BROKEN ANCHOR REMAINED INSIDE THE PATIENT'S BODY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-1588TB). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 25285769 ↗
• MalfunctionJun 18, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, THE SWIVELOCK ANCHORS HAVE EITHER BROKEN OFF OR THE THREAD HAS TURNED THROUGH, DESPITE USING A DRILL AND TAP. THE BROKEN PIECES HAVE BEEN RETRIEVED FROM THE PATIENT. 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. UPDATE CMACKENBACH 03-JUN-2025 FURTHER INFORMATION WAS RECEIVED THAT THE FIRST TIME, THE SWIVELOCK BROKE OFF (AT THE BOTTOM OF THE TIP) FROM THE AR-1593 SET. THE SECOND TIME WITH THE SAME PATIENT, THE SWIVELOCK WAS STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282907 ↗
• MalfunctionJun 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL SUTURE SURGERY THE ANCHOR BROKE AT THE DISTAL FIXATION. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. 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. UPDATE DW 05-MAR-2025: FURTHER INFORMATION WAS PROVIDED THAT TWO ADDITIONAL SETS HAVE FAILED DURING THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158384 ↗
• MalfunctionJun 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL SUTURE SURGERY THE ANCHOR BROKE AT THE DISTAL FIXATION. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. 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.***UPDATE DW 05-MAR-2025:FURTHER INFORMATION WAS PROVIDED THAT TWO ADDITIONAL SETS HAVE FAILED DURING THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22158374 ↗
• MalfunctionFeb 26, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL SUTURE SURGERY THE ANCHOR BROKE AT THE DISTAL FIXATION. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. 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 21470846 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED THAT DURING A LIGAMENT SURGERY THE ANCHOR BROKE. ALL PARTS WERE RETRIEVED FROM THE PATIENT. 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 21264709 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED THAT DURING A SIDEBANDS SURGERY THE ANCHOR BROKE, ALTHOUGH MADE WITH THE CORRECT DRILL AND TAP ACCORDING TO THE SURGEON. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. 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 21264669 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED THAT DURING A SIDEBANDS SURGERY THE ANCHOR BROKE, ALTHOUGH MADE WITH THE CORRECT DRILL AND TAP ACCORDING TO THE SURGEON. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. 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 21264635 ↗
• MalfunctionMay 16, 2024Break; Break

  ON 08/20/2021 IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1593 BECAME STUCK DURING INSERTION. THE SURGEON ATTEMPTED TO CUT THE TAP WITH A DRILL TO FIX THE THREAD BUT THE INSERTER BROKE. THIS WAS DISCOVERED DURING USE IN A MENISCAL REPAIR ON 08/17/2021. THE CASE WAS COMPLETED WITH A NEW AR-1593.

  Patient problems: Insufficient Information

  MAUDE report 19330083 ↗