Arthrex® AR-1588RTTRecalls & reported problems

Summary

The FDA's MAUDE database contains 148 adverse event reports that list this exact device (DI 00888867308459), received between Jun 7, 2021 and Sep 9, 2026 — classified as 2 injuries, 146 malfunctions.

The most frequently reported specific device problem is “Break” (46 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 148 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Material Split, Cut or Torn

  It was reported that during an anterior cruciate ligament surgery the suture tore. 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 50690939 ↗
• MalfunctionApr 22, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE TORE DURING INSERTION OF 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 24952959 ↗
• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY THE SUTURE ON THE IMPLANT BROKE DURING INSERTION. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818483 ↗
• MalfunctionMar 5, 2026Break

  ON 12-FEB-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-1588RTT ACL FIBERTAG TIGHTROPE IMPLANT ENCOUNTERED ISSUES DURING AN ACL RECONSTRUCTION PERFORMED ON (B)(6) 2026. PASSING AND FLIPPING WERE COMPLETED WITHOUT DIFFICULTY; HOWEVER, THE SURGEON EXPERIENCED RESISTANCE WHEN ADJUSTING THE GRAFT INTO THE BONE TUNNEL. THE GRAFT WAS EVENTUALLY ADVANCED, BUT TWO ADJUSTMENT THREADS BROKE DURING SUBSEQUENT TENSIONING. WHEN ATTEMPTING TIBIAL FIXATION, THE GRAFT BACKED OUT IN THE OPPOSITE DIRECTION, AND THE LOOP WAS FOUND TO BE COMPLETELY BROKEN. THE PROCEDURE WAS COMPLETED USING A NON-ARTHREX DEVICE, AND NO COMPONENTS REMAINED IN THE PATIENT. NO SIGNIFICANT SURGICAL DELAY, ADDITIONAL ANESTHESIA, OR PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24519166 ↗
• MalfunctionFeb 27, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE ANTERIOR CRUCIATE LIGAMENT SURGERY OF THE RIGHT KNEE, THE SUTURE WAS TORN OUT OF THE GRAFT DURING FEMORAL 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 24472602 ↗
• MalfunctionFeb 25, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE DEVICE TORE WHEN 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 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 24442620 ↗
• MalfunctionFeb 25, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE ARTHROSCOPY FOR THE RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT, THE TIGHTROPE TORE WHILE BEING INSERTED INTO THE DRILL HOLE. 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 24442236 ↗
• MalfunctionJan 12, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE PULLED OUT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY BECAUSE THE TIGHTROPE WAS FIXED FOMARALLY WITH A SCREW. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035734 ↗
• MalfunctionJan 12, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE PULLED OUT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY BECAUSE THE TIGHTROPE WAS FIXED FOMARALLY WITH A SCREW. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035310 ↗
• MalfunctionDec 10, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY WITH QUAD TENDON THE PRODUCT WAS INTEGRATED INTO THE Q-TENDON GRAFT. AFTER THE PRODUCT WAS SUTURED IN PLACE, IT WAS NOTICED THAT THE WHITE SUTURE WAS NOT PULLING, INDICATING A PRODUCT DEFECT, AS IT WOULD OTHERWISE BE MOBILE. THE PRODUCT WAS REMOVED AND REPLACED WITH ANOTHER ACL FIBER TAG THIGHT ROPE. 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 23769079 ↗
• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE BROKE WHILE PULLING IT IN. 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 23743765 ↗
• MalfunctionOct 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE TORE WHILE PULLING INTO THE DRILLING CHANNEL. 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 23309577 ↗
• MalfunctionOct 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE TORE WHILE PULLING INTO THE BONE CHANNEL. 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 23299505 ↗
• MalfunctionSep 18, 2025Break; Break

  ON 08/29/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-1588RTT ACL FIBERTAG TIGHTROPE IMPLANT WAS SUCCESSFULLY SUTURED AND FIXED TO THE GRAFT. HOWEVER, THE WHITE LOOP SUTURE BROKE WHILE PASSING THROUGH THE KNEE JOINT, CAUSING THE BUTTON AND GRAFT TO DISINTEGRATE AND BECOME UNUSABLE. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT AR-1588RTT ACL FIBERTAG TIGHTROPE IMPLANT. THERE WAS NO SIGNIFICANT DELAY, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE EFFECTS WERE REPORTED. NO DETAILS WERE PROVIDED REGARDING BONE PREPARATION OR THE QUALITY OF THE PATIENT'S BONE. THE ISSUE OCCURRED DURING AN ACL RECONSTRUCTION PERFORMED ON (B)(6) 2025, WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088860 ↗
• MalfunctionSep 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 4TH SEPTEMBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1588RTT, ACL FIBERTAG® TIGHTROPE® IMPLANT, THE NEEDLE CAME OFF FIBERTAG TIGHTROPE AND TIGHTROPE WAS UNABLE TO BE STITCHED. THIS WAS DETECTED AN UNSPECIFIED PROCEDURE ON (B)(6) 2025. (B)(6) 2025 - THE COMPLAINT INITIATOR REPLIED THAT THIS WAS DETECTED DURING AN ACL PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A NEW IMPLANT WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991608 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE THREAD BROKE DURING SEWING. 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 22885477 ↗
• MalfunctionAug 22, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING THE ANTERIOR CRUCIATE LIGAMENT SURGERY THAT THE NEEDLE BROKE OFF THE LOOP. THE BROKEN PIECES 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 22873295 ↗
• MalfunctionAug 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 7/25/2025, AN EMPLOYEE OF AN ARTHREX SUBSIDIARY REPORTED VIA EMAIL THAT DURING AN ACL REPAIR PROCEDURE ON (B)(6) 2025, AN AR-1588RTT ACL TIGHTROPE WITH FIBERTAG BECAME UNUSABLE WHEN THE THREAD DETACHED FROM THE NEEDLE. THE CASE WAS COMPLETED USING A NEW AR-1588RTT ACL TIGHTROPE WITH FIBERTAG. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 08/01/2025: THIS ISSUE OCCURRED INSIDE THE PATIENT. THE NEEDLE AND SUTURES WERE REMOVED FROM THE PATIENT. THERE WAS NO CASE DELAY OR ADDED ANESTHESIA ADMINISTERED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22838360 ↗
• MalfunctionAug 6, 2025Material Frayed; Material Frayed

  ON 22ND JULY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1588RTT, ACL TIGHTROPE WITH FIBERTAG, FOLLOWING THE FIRST PASS OF SUTURE THE SURGEON NOTICED THE FIBERTAG COMPONENT OF AR-1588RTT WAS FRAYED. THIS WAS CLEARLY VISIBLE AND THE DECISION TO CUT FIBERTAG OFF TO AVOID DAMAGE TO GRAFT WAS MADE. THIS WAS DETECTED DURING USE IN A MCL RECONSTRUCTION PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER AR-1588RTT WAS OPENED.

  Patient problems: Insufficient Information

  MAUDE report 22729875 ↗
• MalfunctionJun 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE SURGERY THE NEEDLE DETACHED FROM THE SUTURE. 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 22337892 ↗
• MalfunctionJun 13, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE SUTURE TORE DURING IMPLANT INSERTION. 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 22205080 ↗
• MalfunctionMay 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ACL SURGERY BOTH SUTURES RIPPED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT SURGICAL TECHNIQUE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079395 ↗
• MalfunctionMay 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ACL SURGERY BOTH SUTURES RIPPED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT SURGICAL TECHNIQUE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079151 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY, THE SUTURE BROKE OFF THE NEEDLE THE FIRST TIME IT WAS PIERCED (WITHOUT MUCH FORCE). 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 22025915 ↗
• MalfunctionMay 2, 2025Positioning Failure; Defective Device; Positioning Failure; Defective Device

  ON 04/04/2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-1588RTT ACL TIGHTROPE FIBERTAG SUTURES WERE TOO LOOSE TO ATTACH TO GRAFT CLAMP. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953829 ↗