Arthrex® AR-1588TNTRecalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 00888867308466), received between May 12, 2021 and Mar 13, 2026 — classified as 3 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Break” (30 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Break

  IT WAS REPORTED THAT DURING THE ARTHROSCOPIC STABILIZATION OF THE GRAFT IN THE TIBIAL TUNNEL, THE SECURING SUTURE BROKE, NECESSITATING THE USE OF ANOTHER IMPLANT. THE SURGEON DECIDED TO CHANGE THE METHOD OF GRAFT FIXATION, TO A 9X30 PEEK SCREW WHICH WAS USED ACCORDING TO THE TECHNIQUE (TIBIAL TUNNEL WIDTH 9.5MM), BUT THE SCREW WAS SEATED TOO LOOSELY IN THE TUNNEL, REQUIRING THE USE OF A DIFFERENT IMPLANT TO FINISH THE SURGERY SUCCESSFULLY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24593937 ↗
• MalfunctionMar 10, 2026Break

  ON 17 FEBRUARY 2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588TNT, ACL TIGHTROPE WITH FIBERTAG ABS WAS REPORTED TO HAVE FAILED DURING USE. IT WAS REPORTED THAT ACL FIBERTAG TIGHTROPE ABS IMPLANT SNAPPED DURING TENSIONING AT THE TIBIA. ACCORDING TO THE REPRESENTATIVE, THE SURGEON WAS NOT USING EXCESSIVE FORCE DURING THE IMPLANT MALFUNCTION. THIS OCCURRED ON (B)(6) 2026 DURING AN ACL RECONSTRUCTION, QUAD GRAFT. THE CASE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATIVE TECHNIQUE TO COMPLETE REPAIR. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 24556772 ↗
• MalfunctionMar 3, 2026Defective Device

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE LOCKING MECHANISM WAS DEFECTIVE. THE DEVICE REMAINED IN THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY BY FIXATING TIBIALLY WITH A METAL SCREW AND A SWIVELOCK. IT WAS NOT NECESSARY DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24495548 ↗
• MalfunctionFeb 4, 2026Break

  ON 14-JAN-2026, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-1588TNT ACL-FIBERTAG-TIGHTROPE ABS DEVICE BROKE DURING INSERTION AND TIGHTENING ON THE TIBIAL SIDE. THE ISSUE OCCURRED DURING A QUADLINK PROCEDURE ON (B)(6) 2025. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED ON 16-JAN-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257284 ↗
• MalfunctionJan 26, 2026Break

  ON 09-JAN-2026, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-1588TNT ACL FIBERTAG TIGHTROPE ABS IMPLANT BROKE WHILE BEING TENSIONED. THIS WAS DISCOVERED DURING A QUADLINK PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 14-JAN-2026: THE BROKEN TIGHTROPE WAS REMOVED FROM THE PATIENT. A REPLACEMENT AR-1588TNT ACL FIBERTAG TIGHTROPE ABS IMPLANT WAS USED TO COMPLETE THE CASE. THE CASE WAS DELAYED FOR AN UNKNOWN PERIOD TO RESUTURE THE QUADRICEPS TENDON, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179736 ↗
• MalfunctionDec 29, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1588TNT, ACL-FIBERTAG®-TIGHTROPE® ABS-IMPLANTAT, THE SUTURES SNAPPED WHEN SUTURING THE GRAFT. THIS WAS DETECTED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION RECEIVED ON 8TH DEC: THIS WAS DETECTED DURING AN ACL REPAIR (QUADS) ON 8TH DEC 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY OPENING AN ADDITIONAL FIBERTAG. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906626 ↗
• MalfunctionSep 17, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE TORE WHEN FIRST PIERCING THROUGH THE TENDON. 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 23072912 ↗
• MalfunctionSep 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE NEEDLE OF THE DEVICE TORE OFF DURING THE FIRST PUNCTURE. 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 23051640 ↗
• MalfunctionAug 1, 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 22686558 ↗
• MalfunctionJul 8, 2025Defective Device; Defective Device

  ON 06/12/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1588TNT ACL-FIBERTAG®-TIGHTROPE® ABS-IMPLANT WAS PREPPED, AND WHEN REMOVING THE TIGHTROPE OFF THE CARD, IT CAME ON; ONE OF THE CINCHES WAS ALREADY CINCHED ALL THE WAY DOWN AND COULD NOT BE LOOSENED. THIS OCCURRED DURING AN ACL RECONSTRUCTION ON 06/12/2025, WHEN THE GRAFT WAS PREPPED, AND WHEN REMOVING THE TIGHTROPE OFF THE CARD, ONE OF THE CINCHES WAS ALREADY CINCHED ALL THE WAY DOWN AND COULD NOT BE LOOSENED. THE DEVICE WAS REMOVED FROM THE PATIENT. THE CASE CONTINUED USING ANOTHER AR-1588TNT ACL-FIBERTAG®-TIGHTROPE. THERE WAS ABOUT A 20-MINUTE DELAY WHERE ADDITIONAL ANESTHESIA WAS NOT ADMINISTERED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440046 ↗
• MalfunctionJul 8, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY, THE CHINESE TRAP 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. UPDATE DW 17-JUN-2025: FURTHER INFORMATION WAS PROVIDED THAT THE REPORTED DEVICE TORE WHILE IT WAS TIGHTENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437387 ↗
• MalfunctionMay 23, 2025Positioning Failure; Positioning Failure

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588TNT ACL TIGHTROPE WITH FIBERTAG, ABS WAS REPORTED TO HAVE ONE OF THE TENSIONABLE STRANDS OF THE ABS WAS SHORTENED SO MUCH IT WAS UNABLE TO BE TENSIONED. THIS OCCURRED ON (B)(6) 2025 DURING A QUAD TENDON PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY USING AN OPEN ABS AR-1588TN-21. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 22078676 ↗
• MalfunctionApr 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ACL SURGERY IT WAS NOTICED DURING SEWING THAT THE THREAD WAS OUT OF THE LOOP DURING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753810 ↗
• MalfunctionFeb 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN NATERIOR CRUCIATE LIGAMENT SURGERY THE NEEDLE OF THE DEVICE TORE OFF THE FIRST TIME IT WAS PIERCED THROUGH TISSUE. 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 21303850 ↗
• MalfunctionNov 27, 2024Break; Break

  ON 11/05/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS-06704031 THAT AN AR-1588TNT ACL-FIBERTAG®-TIGHTROPES NEEDLE SEPARATED FROM THE SUTURE ON THE FIRST PASSAGE. THIS OCCURRED DURING A QUADLINK , SO A SECOND IMPLANT HAD TO BE OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797625 ↗
• MalfunctionNov 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 04 NOVEMBER 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588TNT ACL TIGHTROPE WITH FIBERTAG, ABS WAS REPORTED TO HAVE DETACHED FROM THE CARD. THIS OCCURRED ON 04 NOVEMBER 2024 IN (B)(6) HOSPITAL ROTORUA DURING A QUADS ACL SURGERY. IT WAS REPORTED THAT THE TIGHTROPE WAS FIXATED TO THE QUAD AUTOGRAFT, HOWEVER WHEN THE TIGHTROPE WAS DETACHED FROM THE WORKING CARD THE TIGHTROPE ENDS HAD NOT BEEN FORMED INTO A COMPLETE TIGHTROPE, MAKING THE PRODUCT UNUSABLE. THE CASE WAS COMPLETED SUCCESSFULLY USING AN AR-1588BTB. THERE WAS CASE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784356 ↗
• MalfunctionNov 7, 2024Break; Break

  ADDITIONAL INFORMATION WAS PROVIDED ON 10/29/2024 WHERE IT WAS STATED THAT THIS OCCURRED DURING GRAFT PREPARATION, WHICH WAS ALL TENDON, A FLIPCUTTER III WAS USED TO PREPARE THE BONE, HOWEVER, THE NEEDLE BROKE OFF DURING TENDON PREP, LONG BEFORE THE TENDON WAS PASSED INTO THE BONE SOCKET. THERE WAS NO DELAY, AND THEY ARE UNSURE IF ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 20631517 ↗
• MalfunctionSep 30, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE OF THE DEVICE BROKE WHILE TIGHTENING THE LOOP. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 20339068 ↗
• MalfunctionSep 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT QUAD SURGERY THE NEEDLE BECAME DETACHED FORM THE SUTURE WHEN IT IS PULLED THROUGH THE TENDON. 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 20310110 ↗
• MalfunctionSep 25, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE CAME OUT OF THE NEEDLE DURING THE FIRST STITCH. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 20305448 ↗
• MalfunctionSep 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE NEEDLE DETACHED FROM THE SUTURE WHEN PULLING THROUGH THE QUAD TENDON. 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 20301110 ↗
• MalfunctionSep 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A REVISION ANTERIOR CRUCIATE LIGAMENT SURGERY WITH QUAD TENDON THE STRAIGHT NEEDLE CAME OFF THE FIBERTAPE ABS TIGHTROPE ON THE FIRST PASS THROUGH TENDON. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 20269179 ↗
• MalfunctionSep 20, 2024Defective Device; Defective Device

  ON 12TH SEPTEMBER 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT FOR AN AR-1588TNT, ACL-FIBERTAG®-TIGHTROPE® ABS-IMPLANTAT, 1 OUT OF THE 2 SHORTENING LIMBS (WHITE IN COLOUR) OF THE FIBERTAG ABS IMPLANT WAS UNABLE TO BE SHORTENED. THIS WAS DETECTED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2024. IT WAS DURING THE FINAL STEP WHERE THE SURGEON STRUGGLED AND SHORTENED 1 LIMB COMPLETELY AND WAS UNABLE TO SHORTEN THE OTHER LIMB AT ALL. THIS RESULTED IN THE ABS BUTTON NOT SITTING PROPERLY ON THE TIBIA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE SUTURES WERE TIED OVER THE BUTTON INSTEAD OF UTILIZING THE KNOTLESS MECHANISM.

  Patient problems: Foreign Body In Patient

  MAUDE report 20265930 ↗
• MalfunctionSep 19, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE OF THE DEVICE CAME LOOSE FROM THE END OF THE NEEDLE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 20255861 ↗
• MalfunctionSep 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 8/21/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT THE NEEDLE FROM AN AR-1588TNT ACL-FIBERTAG TIGHTROPE ABS FELL OFF THE SUTURE DURING THE FIRST PASS. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 8/28/2024: THIS WAS DISCOVERED DURING A QT ACL PROCEDURE ON (B)(6) 2024. THE NEEDLE DETACHED FROM THE SUTURE WHILE IT WAS INSIDE THE PATIENT. ALL THE FRAGMENTS WERE RETRIEVED. THE CASE WAS DELAYED TWELVE MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 20211836 ↗