Arthrex® AR-1588TNT2Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00888867426696), received between Oct 16, 2023 and Feb 19, 2026 — classified as 2 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT WITH QUAD TENDON SURGERY THE LOCKING MECHANISM FAILED ON BOTH DEVICES AR-1588RTT2-IB (LOT: 15375803) AND AR-1588TNT2 (LOT: 15402435). THE DEVICES REMAINED INSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (BIOSUREPK SCREWS). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24391046 ↗
• MalfunctionJan 20, 2026Break

  ON 5-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1288RTT2-FC3 FIBERTAG TIGHTROPE II EXPERIENCED AN ISSUE DURING USE. UPON PASSING THE GRAFT AND TENSIONING THE TIBIAL SIDE, THE TIGHTROPE INTERFACE BROKE DURING TENSIONING. THE FAILURE OCCURRED TWICE CONSECUTIVELY. AS A RESULT, THE TIBIAL BUTTON AND THE FEMORAL-SIDED TIGHTROPE WERE CUT OUT TO ALLOW FOR RE-SUTURING. THIS WAS DISCOVERED DURING A PEDIATRIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 08-JAN-2026: THE TWO TIGHTROPES THAT BROKE WERE THE TIBIAL-SIDED AR-1588TNT2 FIBERTAG TIGHTROPE II ABS. BECAUSE THE TIBIAL TIGHTROPE FAILED, THE ENTIRE CONSTRUCT HAD TO BE REMOVED AND THE SITE RE-PREPPED. THIS ISSUE OCCURRED WHILE THE IMPLANTS WERE IN THE PATIENT. ONCE THE TIGHTROPE SUTURES BROKE, ALL COMPONENTS WERE REMOVED AND THE SITE WAS RE-PREPARED USING PRODUCTS FROM ANOTHER MANUFACTURER, RESULTING IN A SURGICAL DELAY OF APPROXIMATELY 1.75 HOURS. ACCORDING TO THE SALES REPRESENTATIVE, NO ADDITIONAL ANESTHESIA WAS REQUIRED, AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115890 ↗
• MalfunctionJan 6, 2026Detachment of Device or Device Component

  ON 18TH DECEMBER 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1588TNT2, FIBERTAG® TIGHTROPE® II ABS IMPLANT, THE NEEDLE ON THE TIGHTROPE BROKE OFF THE SUTURE WHEN THE SURGEON WAS WHIPSTITCHING GRAFT. THIS WAS DETECTED DURING AN ACL RECONSTRUCTION ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A NEW TIGHTROPE WAS OPENED AND THE PROCEDURE CONTINUED.

  Patient problems: Insufficient Information

  MAUDE report 23978094 ↗
• MalfunctionDec 10, 2025Positioning Failure; Positioning Failure

  ON 11/20/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1588TNT2 FIBERTAG TIGHTROPE II ABS IMPLANT FAILED DURING USE INSIDE THE PATIENT. THE KNOTLESS MECHANISM OF THE SADDLE DID NOT FULLY TIGHTEN. THE CASE WAS COMPLETED BY CUTTING THE TIGHTROPE AND CONVERTING TO AN AR-1593-BC SECONDARY FIXATION WITH BIOCOMPOSITE SWIVELOCK ANCHOR. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 45 MINUTES, WITH NO ADDITIONAL ANESTHESIA ADMINISTERED TO THE PATIENT. THIS ISSUE OCCURRED DURING AN ACL PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767465 ↗
• MalfunctionNov 21, 2025Break; Break

  ON 11/03/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1588TNT2 FIBERTAG® TIGHTROPE® II ABS IMPLANT, AND AN AR-1588TB-5 TIGHTROPE® ABS BUTTON BROKE. THIS OCCURRED DURING A QUAD TENDON ACL RECONSTRUCTION ON (B)(6) 2025. WHEN THE SURGEON BEGAN TENSIONING THE AR-1588TNT2 BROKE RESULTING IN THE AR-1588TB-5 BUTTON BREAKING AND FALLING OUT TO THE FLOOR. ALL FRAGMENTS WERE RECOVERED FROM THE PATIENT. THE PATIENT HAD A GOOD BONE QUALITY, AND IT WAS UNCERTAIN IF ANYTHING WAS USED TO PREPARE THE BONE. THERE WAS A DELAY OF ABOUT 30 MINUTES THAT REQUIRED ADDITIONAL ANESTHESIA FOR THAT TIME. THE PROCEDURE WAS COMPLETED USING ANOTHER AR-1588TNT2 FIBERTAG® TIGHTROPE® II ABS IMPLANT, AND ANOTHER AR-1588TB-5 TIGHTROPE® ABS BUTTON. THERE WAS NO HARM ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618448 ↗
• MalfunctionMay 20, 2025Positioning Failure; Positioning Failure

  ADDITIONAL INFORMATION HAS BEEN RECEIVED ON 5/20/2025: AN AUTOGRAFT QUAD TENDON ACL RECONSTRUCTION PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, A DELAY OF APPROXIMATELY 10 MINUTES WAS REPORTED DUE TO IDENTIFIED ISSUES. HOWEVER, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED BEYOND THE EXPECTED DURATION, WITH THE PATIENT REMAINING UNDER FOR AN ADDITIONAL 10 MINUTES. NO SURGICAL INSTRUMENTS OR IMPLANTS BROKE, AND NO FRAGMENTS WERE ENCOUNTERED DURING THE PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22052633 ↗
• MalfunctionMay 12, 2025Break; Break

  ON 04/14/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1588TNT2 FIBERTAG TIGHTROPE II ABS IMPLANT HAD BROKEN BEFORE IT COULD BE FULLY USED. NO FURTHER DETAILS WERE PROVIDED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED IF THIS OCCURRED ON THE BACK TABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001732 ↗
• MalfunctionMay 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY WITH QUAD TENDON THE NEEDLE OF THE DEVICE TORE OFF FROM THE TIGHTROPE WHILE THE SURGEON WAS STITCHING 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 21996366 ↗
• MalfunctionMay 2, 2025Break; Break

  ON 04/04/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588TNT2 FIBERTAG TIGHTROPE WHITE SUTURE ON THE TIGHTROPE SNAPPED AND FAILED WHILE TENSIONING THE CONSTRUCT. THIS WAS DISCOVERED DURING USE IN A CASE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953854 ↗
• InjuryApr 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT CALLED IN AN INQUIRY ABOUT THE MATERIAL COMPOSITION FOR THE AR-1588AL-CP2 IMPLANT SYSTEM, AR-1588TNT2 FIBERTAG TIGHTROPE II ABS, AR-1588RTT2-IB FIBERTAG® TIGHTROPE® II IMPLANT, AR-5511-CP IMPLANT SYSTEM, AND AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK® ANCHOR. THERE WAS NO ALLEGATION OF PRODUCT DEFICIENCY OR ADVERSE EVENTS REPORTED WITHIN THIS INQUIRY. ON (B)(6) 2025, IT WAS REPORTED BY THE PATIENT VIA PHONE THAT SHE UNDERWENT AN ACL RECONSTRUCTION ON (B)(6) 2024 WHERE THE AR-1588AL-CP2 IMPLANT SYSTEM, AR-1588TNT2 FIBERTAG TIGHTROPE II ABS, AR-1588RTT2-IB FIBERTAG® TIGHTROPE® II IMPLANT, AR-5511-CP IMPLANT SYSTEM, AND AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK® ANCHOR WERE IMPLANTED. THE PATIENT BEGAN TO EXPERIENCE AN ALLERGIC REACTION IN (B)(6) 2024 THE ALLERGIC REACTION WAS CONFIRMED BY A PHYSICIAN. THE PATIENT HAD A VISIBLE RASH, BLISTERS, AND OOZING OUT THE INCISIONS. HER LEG, KNEE, AND ANKLE WERE SWOLLEN WITH FLUID. IT WOULD GO AND COME, THIS HAPPENED UNTIL THE PROCEDURE IN (B)(6) 2024 WHERE THEY WENT IN AND CLEANED SCAR TISSUE. AFTER THIS PROCEDURE, THE REACTION WORSENED IT SPREAD TO THE WHOLE RIGHT LEG. THIS HAS BEEN AN ON AND OFF ISSUE SINCE

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21911313 ↗
• InjuryApr 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 3/26/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A WASH OUT PROCEDURE WAS CONDUCTED FOR AN INFECTION FOLLOWING A QUAD AUTOGRAFT ACL RECONSTRUCTION WITH INTERNAL BRACE 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 INTERNAL BRACE, 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 MAN

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 21881730 ↗
• MalfunctionJan 23, 2025Break; Break

  ON 12/30/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1588TNT2 FIBERTAG TIGHTROPE AND AN AR-1588TB-3IB TIGHTROPE ABS TENSIONING STRANDS BROKE AT THE BUTTON. THIS WAS DISCOVERED DURING THE CASE. THE CASE WAS DELAYED 30 MINUTES AND ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217184 ↗
• MalfunctionJan 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588TNT2 FIBERTAG TIGHTROPE II ABS IMPLANT HAD AN OUT-OF-BOX ISSUE. WHEN OPENING THE COMPLAINT DEVICE BEFORE USE IN AN ACL PROCEDURE ON (B)(6) 2024, IT WAS NOTICED THAT THE BACK SIDE WAS NOT ORGANIZED WELL IN SEPARATING THE SUTURE INTO LEFT AND RIGHT; IT WAS NOT ARRANGED IN ITS NORMAL WAY. THE SURGEON WAS MADE AWARE OF IT BUT, DECIDED TO PROCEED WITH USING THE DEVICE IN THE PROCEDURE. WHEN PASSING THROUGH THE TIBIA TUNNEL USING BLUE FIBERTAG STITCH, THE WHITE STITCHES PULLED COMPLETELY OUT OF THE TIBIA TUNNEL AND OUT OF THE TIGHTROPE, UNRAVELING THE ENTIRE IMPLANT. IT LEFT THEM WITH NO STITCHES COMING OUT OF THE TUNNEL AND UNABLE TO ATTACH A BUTTON TO THE TIGHTROPE, SO THE IMPLANT COULD NOT BE FIXATED. NOTHING BROKE INSIDE THE PATIENT; THE SUTURES CAME UNTETHERED AND WERE REMOVED FROM THE PATIENT. A PART OF THE FIBERTAG TIGHTROPE II ABS IMPLANT FIXATED TO THE GRAFT WAS LEFT INSIDE THE PATIENT AND WAS FIXATED WITH AN AR-7501 SUTURETAPE AND AN ADDITIONAL AR-1588TB-3IB TIGHTROPE ABS BUTTON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. A CASE DELAY OF 20 MINUTES WAS REPORTED, BUT IT

  Patient problems: Foreign Body In Patient

  MAUDE report 21083306 ↗
• MalfunctionMar 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 2/27/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588TNT2 FIBERTAG TIGHTROPE II ABS NEEDLE CAME OFF THE SUTURES. ANOTHER AR-1588TNT2 FIBERTAG TIGHTROPE II ABS WAS OPENED, AND THE NEEDLE BROKE OFF AFTER THE FIRST PASS THROUGH THE TENDON. THIS WAS DISCOVERED DURING A QUAD TENDON ACL PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 18921661 ↗
• MalfunctionMar 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 2/27/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588TNT2 FIBERTAG TIGHTROPE II ABS NEEDLE CAME OFF THE SUTURES. ANOTHER AR-1588TNT2 FIBERTAG TIGHTROPE II ABS WAS OPENED, AND THE NEEDLE BROKE OFF AFTER THE FIRST PASS THROUGH THE TENDON. THIS WAS DISCOVERED DURING A QUAD TENDON ACL PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 18921656 ↗
• MalfunctionFeb 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 2/5/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588TNT2 FIBERTAG TIGHTROPE II ABS IMPLANT NEEDLE POPPED OFF. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 2/16/2024: THIS WAS DISCOVERED DURING AN ACL PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS COMPLETED USING ANOTHER AR-1588TNT2 FIBERTAG TIGHTROPE II ABS, AND IT WAS MINIMALLY DELAYED. ADDITIONAL ANESTHESIA WAS NOT NEEDED, AND THE PATIENT SUFFERED NO NEGATIVE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778089 ↗
• MalfunctionFeb 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588TNT2 FIBERTAG TIGHTROPE II ABS IMPLANT NEEDLE POPPED OFF. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 2/16/2024: THIS WAS DISCOVERED DURING AN ACL PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS COMPLETED USING ANOTHER AR-1588TNT2 FIBERTAG TIGHTROPE II ABS, AND IT WAS MINIMALLY DELAYED. ADDITIONAL ANESTHESIA WAS NOT NEEDED, AND THE PATIENT SUFFERED NO NEGATIVE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778002 ↗
• MalfunctionFeb 6, 2024Material Frayed; Material Frayed

  ON 01/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1588TNT2 FIBERTAK SUTURE WIRE WAS FRAYED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. PER FACILITY: "THE AREA WHERE THE TAPE SWEDGES INTO THE #2 SUTURE LOOKED FRAYED AND WE DID NOT WANT TO PROCEED WITH THAT IMPLANT. WE HAD ONLY MADE ONE PASS THROUGH TENDON, SO THERE WAS NO NEEDLE PASSES THROUGH ANY OF THE FIBERTAG TAPE AREA." CASE COMPLETED USING A SECOND IMPLANT IN STANDARD FASHION WITHOUT ANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651441 ↗
• MalfunctionJan 30, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED ON 1/17/2024: ALL FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED BY OPENING A NEW IMPLANT TO FINISH THE CASE. THERE WERE NO PHOTOS TAKEN.

  Patient problems: Insufficient Information

  MAUDE report 18605336 ↗
• MalfunctionJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588TNT2 FIBERTAG IMPLANT SUTURE POPPED OFF THE NEEDLE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. "THE PHYSICIAN ASSISTANT PLACED THE CARD WITHIN THE SLOT ON THE CLAMP. THEY THEN CLAMPED DOWN ON THE TISSUE GRAFT AND WENT TO MAKE THE FIRST NEEDLE PASS. WHEN THE PHYSICIAN ASSISTANT WENT TO PULL THE NEEDLE WITH SUTURE THROUGH THE GRAFT, THE SUTURE POPPED OFF THE NEEDLE. WE PROCEEDED BY OPENING ANOTHER AR-1588TNT2. THE REST OF THE CASE WENT SMOOTHLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552767 ↗
• MalfunctionJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588TNT2 FIBERTAG TIGHTROPE II ABS NEEDLE CAME OFF THE SUTURE BEFORE IT WAS PASSED THROUGH THE TENDON. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION REQUESTED

  Patient problems: Insufficient Information

  MAUDE report 18551954 ↗
• MalfunctionJan 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 12/18/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588TNT2 FIBERTAG NEEDLE PULLED OFF THE IMPLANT WHILE SUTURING. THIS WAS DISCOVERED DURING USE IN A CASE WITH NO PATIENT EFFECT. NEEDLE REMOVED FROM PATIENT. DELAY < 15 MINUTES. CASE COMPLETED OPENING ANOTHER TIGHTROPE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18496592 ↗
• MalfunctionDec 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 11/8/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588TNT2 FIBERTAG TIGHTROPE II ABS IMPLANT HAD AN ISSUE. WHEN THE NEEDLE WAS INSERTED INTO THE QUAD TENDON DURING GRAFT PREPARATION, IT PULLED AWAY FROM THE SUTURE. THE CASE WAS COMPLETED USING ANOTHER AR-1588TNT2 FIBERTAG TIGHTROPE II ABS IMPLANT WITH NO DELAY IN THE PROCEDURE AND NO FRAGMENTS INSIDE THE PATIENT. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2023, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268507 ↗
• MalfunctionNov 28, 2023Break; Break

  ON 10/30/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588TNT2 FIBERTAG TIGHTROPE II NEEDLE BROKE OFF THE SUTURE. THIS OCCURRED ON THE FIRST PASS THROUGH THE QUAD GRAFT. ANOTHER TIGHTROPE WAS OPENED AND THE CASE WAS COMPLETED. THIS WAS DISCOVERED DURING AN ACL PROCEDURE ON (B)(6) 2023. THE CASE WAS DELAYED A FEW MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 18220429 ↗
• MalfunctionNov 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588TNT2 FIBERTAG® TIGHTROPES NEEDLE WAS PULLED OFF OF THE SUTURE SWEDGE AND COULD NOT BE USED. THIS OCCURRED DURING A QUAD ACL PROCEDURE ON (B)(6) 2023, WHERE A SECOND AR-1588TNT2 WAS USED TO COMPLETE THE CASE. THERE WAS NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18172881 ↗