Arthrex® AR-1588TB-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888867019638), received between Jul 13, 2016 and Sep 18, 2026 — classified as 6 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Break

  It was reported that the device button broke postoperatively. A revision surgery is scheduled for (b)(6) 2026. The revision surgery was finished successfully with a new Fibertag TightRope. No further information has been received to date.

  Patient problems: Failure of Implant

  MAUDE report 50818877 ↗
• MalfunctionMar 17, 2026Break

  IT WAS RERTED THAT DURING A CRUCIATE LIGAMENT SURGERY THE BUTTON BROKE IN THE MIDDLE WHILE TIGHTENING. THE BROKEN 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 24621460 ↗
• MalfunctionFeb 9, 2026Break

  ON 20-JAN-2026, A SALES REPRESENTATIVE REPORTED THAT AN AR-1588TB-1 TIGHTROPE ABS BUTTON SNAPPED IN HALF WHILE CYCLING THE KNEE DURING AN ARTHROSCOPIC ACL RECONSTRUCTION. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE, AND ANOTHER BUTTON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 23-JAN-2026: THE BUTTON WAS FULLY SEATED WITHIN THE TIGHTROPE LOOP BEFORE THE BREAK OCCURRED. ANOTHER AR-1588TB-1 DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS NOT DELAYED, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24294495 ↗
• MalfunctionJan 23, 2026Break

  ON 08-JAN-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-1588TB-1 TIGHTROPE ABS BUTTON BROKE CLEANLY IN HALF WHEN TENSION WAS APPLIED. ALL FRAGMENTS WERE RETRIEVED, AND THE SURGERY WAS COMPLETED USING A NEW AR-1588TB-1 TIGHTROPE ABS BUTTON. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED DURING OR FOLLOWING THE PROCEDURE RELATED TO THIS ISSUE. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE PERFORMED ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163872 ↗
• MalfunctionJan 2, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY, THE BUTTON BROKE WHILE TIGHTENING THE GRAFT. 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 23944211 ↗
• InjuryDec 16, 2025Break; Loosening of Implant Not Related to Bone-Ingrowth; Break; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER AN INITIAL SURGERY ON (B)(6) 2025 THE TIBIAL BUTTON BROKE AND BECAME LOOSE. WHICH RESULTED IN A GRAFT FAILURE HOWEVER THE ABS LOOP WAS FOUND TO BE INTACT. THIS WAS NOTICED DURING THE POST OPERATIVE TESTING. DUE TO THIS FAILURE A REVISION SURGERY WITH AN ADDITIONAL SUTURE GRAFT AND A FIXATION OF A BICORTICAL POST WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Failure of Implant

  MAUDE report 23816543 ↗
• MalfunctionSep 11, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE BUTTON BROKE IN THE MIDDLE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE BY USING ONLY THE SUTURES. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027650 ↗
• InjuryApr 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A WASHOUT PROCEDURE WAS CONDUCTED FOR AN INFECTION FOLLOWING A QUAD AUTOGRAFT ACL RECONSTRUCTION WITH INTERNALBRACE AND MENISCUS REPAIR ORIGINALLY PERFORMED ON (B)(6) 2025. THE PATIENT WAS PROGRESSING WELL IN REHABILITATION POST-SURGERY UNTIL SYMPTOMS INCLUDING FEVER AND KNEE ERYTHEMA DEVELOPED. THE SURGEON EVALUATED THE PATIENT THE FOLLOWING DAY AND CONFIRMED THE INFECTION AFTER DRAINING PUS-LIKE FLUID FROM THE KNEE. THE WASHOUT WAS SCHEDULED URGENTLY. DURING THE PROCEDURE, THE SURGEON COLLECTED SYNOVIAL TISSUE AND FLUID FOR CULTURE ANALYSIS AND THOROUGHLY CLEANED THE INFECTED AREAS, INCLUDING THE INCISIONS ON THE TIBIA AND FEMUR, WHICH CONTAINED INFECTED FLUID. THE ACL HARDWARE WAS LEFT INTACT, AS THE ACL ITSELF APPEARED STABLE. CULTURES WERE SENT FOR TESTING, THOUGH THE SPECIFIC INFECTIOUS ORGANISM REMAINS UNIDENTIFIED. THE INITIAL CASE INVOLVED AN AR-1588RTT2-IB FIBERTAG TIGHTROPE II IMPLANT FOR THE INTERNALBRACE, AN AR-1588TNT2 FIBERTAG TIGHTROPE II ABS, AN AR-1588TB-1 TIGHTROPE ABS BUTTON, AND AN AR-2324PSLC PEEK-SWIVELOCK TO RECONSTRUCT THE ACL. THE MENISCUS WAS REPAIRED USING PRODUCTS FROM ANOTHER MANU

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 21881609 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY WHILE TENSIONING THE TIBIAL TIGHTROPE WITH THE ABS BUTTON, THE BUTTON BROKE INTO TWO PARTS. THE BROKEN PIECE WAS RETRIEVED OUT OF 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. THE ABS TIGHTROPE WAS TIGHTENED AND THEN FIXED A NEW TIGHTROPE WITH THE WIRES OF THE TIGHTROPE AND A STAPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21303790 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE BUTTUN OF THE DEVICE BROKE OF IN TWO PIECES. A LARGER BUTTON WAS USED, FIXATION WITH ETHIBOND SUTURE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 21069073 ↗
• MalfunctionJun 21, 2024Defective Device; Defective Device

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588TB-1 TIGHTROPE ABS BUTTON KNOTLESS MECHANISM WOULD NOT CONVERT. THE CASE WAS COMPLETED USING ANOTHER IMPLANT. THIS WAS DISCOVERED DURING AN ACL PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19584187 ↗
• MalfunctionFeb 2, 2024Break; Break

  ON 11TH JANUARY 2024, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-1588TB-1, TIGHTROPE® ABS, BUTTON, ROUND, Ø 14 MM, BROKE IN HALF DURING THE LAST STEP OF THE PROCEDURE WHEN OUR SCRUB NURSE TECH ASSISTED THE SURGEON IN PUTTING THE ABS BUTTON ON THE TIBIAL SIDE AND IT BROKE IN HALF DURING THE FINAL TENSION BY PULLING THE TIGHTROPE. THIS WAS DETECTED DURING USE IN A KNEE ACL ALL INSIDE PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SECOND BUTTON.

  Patient problems: Insufficient Information

  MAUDE report 18629096 ↗
• MalfunctionDec 6, 2023Break; Break

  ON 11/9/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-1588TB-1 TIGHTROPE ABS BUTTON BROKE IN HALF UPON TENSIONING AND GOT LODGED INTO THE TIBIAL TUNNEL. THE BROKEN FRAGMENTS WERE RETRIEVED, AND THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING AN ACL PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED ON 11/10/2023: THE CASE WAS COMPLETED BY OPENING ANOTHER AR-1588TB-1 TIGHTROPE ABS BUTTON. THE CASE WAS DELAYED FIVE MINUTES, AND NO ADDITIONAL ANESTHESIA WAS NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18279439 ↗
• MalfunctionNov 9, 2023Break; Break

  ON 10/17/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-1588TB-1 ROUND TIGHTROPE ABS BUTTON, 14MM, BROKE INTO TWO PIECES WHEN THE SURGEON FLEXED THE KNEE AFTER PERFORMING THE FINAL TIGHTENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18101595 ↗
• InjuryJun 26, 2023Break; Break

  IT WAS REPORTED THAT AFTER A SUCCESSFULLY SURGERY ON (B)(6) 2022 THE ABS BUTTON SNAPPED IN HALF A FEW WEEKS AFTER THE INITIAL SURGERY. A REVISION SURGERY WAS PERFORMED PRIOR TO THE (B)(6) 2022. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17198708 ↗
• InjuryAug 17, 2020Break

  IT WAS REPORTED THAT A PATIENT HAD UNDERGONE AN ACL RECONSTRUCTION (B)(6) 2020. AT A POST OP VISIT THE AR-1588TB-1, TIGHTROPE ABS 14MM BUTTON (LOT 10727270), WAS OBSERVED TO BE BROKEN IN HALF. THE PATIENT UNDERWENT A SECOND SURGERY (B)(6) 2020 AT THE SAME FACILITY, BY THE SAME SURGEON. DURING THE SECOND SURGERY THE ACL BUTTON WAS REMOVED AND AN INTERFERENCE SCREW WAS UTILIZED TO FIXATE THE ACL ALLOGRAFT. IT WAS REPORTED THAT THE PATIENT DID NOT SUFFER ANY KNOWN OR REPORTED TRAUMA POST THE ORIGINAL PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10414283 ↗
• InjuryJul 13, 2016Break

  IT WAS REPORTED THAT A GRAFTLINK PROCEDURE WAS COMPLETED WITH A TIGHROPE RT ON THE FEMUR AND AN ABS TIGHTROPE, AR-1588TB-1, ON THE TIBIA, SECURED WITH 14MM BUTTON DISTALLY. THE KNEE WAS CYCLED AND TENSIONED AND RETENSIONED. WHEN THE SURGEON FLEXED THE KNEE TO REMOVE THE DRAPES, THE ABS BUTTON SNAPPED IN TWO ACROSS THE LINE OF THE TWO HOLES. THE SURGEON HAD TO REOPEN THE INCISION (SURGICAL INTERVENTION) AND REMOVED THE BROKEN BUTTON AND TIED THE REMAINING SUTURES OVER ANOTHER 14MM BUTTON. CASE WAS ACL REVISION.

  Patient problems: No Code Available

  MAUDE report 5791155 ↗