Arthrex® AR-1588RT-2JRecalls & reported problems

Summary

The FDA's MAUDE database contains 418 adverse event reports that list this exact device (DI 00888867319714), received between Jan 4, 2022 and Sep 17, 2026 — classified as 8 injuries, 410 malfunctions.

The most frequently reported specific device problem is “Break” (191 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 25 most recent of 418 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Loosening of Implant Not Related to Bone-Ingrowth

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801914 ↗
• MalfunctionSep 8, 2026Break

  It was reported that during a surgery the suture broke during tensioning. Per complaint reporter there was no harm for patient, operator or third party. No further information received.Update 28-Aug-2026:Further information was provided that the issue occurred during an anterior cruciate ligament surgery. No parts broke off inside the patient. The surgery was finished successfully with a different device (interference screw) and different surgical technique to fixate with the screws. It was not necessary to do a second surgery.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668953 ↗
• MalfunctionAug 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50495594 ↗
• MalfunctionJul 30, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50086979 ↗
• MalfunctionJul 30, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50082724 ↗
• MalfunctionJul 27, 2026Material Rupture

  Patient problems: Insufficient Information

  MAUDE report 50017313 ↗
• MalfunctionJul 27, 2026Use of Device Problem

  Patient problems: Foreign Body In Patient

  MAUDE report 50009279 ↗
• MalfunctionJul 27, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50009000 ↗
• MalfunctionJul 27, 2026Break; Material Frayed

  Patient problems: Insufficient Information

  MAUDE report 50008638 ↗
• MalfunctionJun 22, 2026Break

  IT WAS REPORTED THAT DURING THE RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT, THE LOOP OF THE TIGHTROPE FAILED AS THE SURGEON PULLED THE GRAFT INTO THE FEMORAL TUNNEL. 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 25576649 ↗
• MalfunctionJun 17, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT, THE LOOP SNAPPED AS THE SURGEON PULLED THE GRAFT INTO THE FEMORAL TUNNEL. THE DEFECTIVE TIGHTROPE WAS REMOVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 25533510 ↗
• MalfunctionMay 20, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE TORE WHILE TIGHTENING THE IMPLANT. 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 25230868 ↗
• MalfunctionMay 19, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH LET THE TIGHTROPE TORE OUT OF THE BUTTON. 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 25217087 ↗
• MalfunctionMay 8, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE SUTURES WERE TORN. 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 25123997 ↗
• MalfunctionMay 8, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE SUTURES WERE TORN. 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 25123986 ↗
• MalfunctionMay 4, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE TORE WHILE INSERTING THE DEVICE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME 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 25073495 ↗
• MalfunctionApr 15, 2026Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT DURING THE RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT, THE TIGHTROPE LOCKING MECHANISM FAILED AND THE SUTURE RUPTURED WHEN THE TIGHTROPE WAS PULLED. 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 24887636 ↗
• MalfunctionApr 15, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE SUTURE OF THE DEVICE FAILED. THE FAILURE OCCURRED AT A CRITICAL MOMENT OF THE OPERATION, WHICH EXPOSED THE PATIENT TO AN EXTENDED PROCEDURE TIME AND THE NEED TO USE AN ADDITIONAL IMPLANT. 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 24885965 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE FEMORAL TIGHTROPE FIXATION SYSTEM BROKE. 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 24843380 ↗
• MalfunctionApr 8, 2026Positioning Failure

  IT WAS REPORTED THAT DURING THE RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT, THE SUTURE FAILED WHEN THE GRAFT WAS INSERTED INTO THE FEMORAL CANAL. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE FROM ANOTHER MANUFACTURER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817042 ↗
• MalfunctionApr 8, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE OF THE DEVICE TORE DURING TIGHTENING. 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 24816211 ↗
• MalfunctionApr 8, 2026Positioning Failure

  IT WAS REPORTED THAT DURING A KNEE SURGERY WHILE TIGHTENING THE DEVICE AT THE TIBIAL END, THE SUTURE SECURING THE ENDO BUTTON CAME LOOSE. THE SURGEON RE-SUTURED IT, BUT THE ACL GRAFT REMAINED SLIGHTLY LOOSE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME 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 24815503 ↗
• MalfunctionApr 8, 2026Positioning Failure

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE BUTTON BECAME LOOSE WHEN THE SURGEON PULLED IN THE GRAFT. THE SURGEON HAD TO REPEAT THE PROCEDURE, RE-SEW THE GRAFT AND REATTACH THE BUTTON. 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 24815423 ↗
• MalfunctionApr 8, 2026Positioning Failure

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE TIGHTROPE BUTTONS CAME LOOSE WHEN PULLING AND RAISING THE GRAFT. THE SURGEON HAD TO REPEAT THE PROCEDURE, RE-SEW THE GRAFT, AND REATTACH A BUTTON. 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 24814816 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY A BREAKAGE OF THE TIGHTROPE DEVICE OCCURRED DURING TIGHTENING. 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 24743224 ↗