Arthrex® AR-1588RTT2-IBRecalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00888867426689), received between Nov 7, 2023 and Mar 13, 2026 — classified as 2 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Break” (32 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Break

  ON 19-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE TIGHTROPE CONSTRUCT ON THE FEMORAL SIDE FROM AR-1288QAI-100 ALL-INSIDE QUADLINK KIT BROKE DURING THE PROCEDURE. THE CASE WAS CONTINUED USING A REPLACEMENT AR-1588RTT2-IB FIBERTAG TIGHTROPE II IMPLANT, WHICH ALSO BROKE. A SECOND AR-1588RTT2-IB FIBERTAG TIGHTROPE II IMPLANT FROM THE SAME LOT WAS THEN OPENED AND FUNCTIONED WITHOUT ISSUE. THE EVENT OCCURRED INTRAOPERATIVELY ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 09-MAR-2026: IT WAS REPORTED THAT AN AR-1588RTT2-IB FIBERTAG TIGHTROPE II IMPLANT DEVICE BROKE WHILE PULLING THE TIGHTROPE THROUGH THE FEMORAL TUNNEL AND TENSIONING IT DOWN DURING AN ACL RECONSTRUCTION PROCEDURE. THE BREAK OCCURRED INSIDE THE PATIENT. BOTH IMPLANTS THAT BROKE WERE REMOVED, AND ANOTHER TIGHTROPE WAS IMPLANTED ON THE FEMORAL SIDE. THE FEMORAL SIDE HAD TO BE REDONE TWICE, RESULTING IN AN APPROXIMATE 15-MINUTE SURGICAL DELAY. NO ADDITIONAL ANESTHESIA INFORMATION WAS REPORTED, OTHER THAN THE DELAY TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING OR FOLLOWING THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597508 ↗
• 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 24390910 ↗
• MalfunctionFeb 18, 2026Break

  ON 30-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588RTT2-IB FIBERTAG IMPLANT BUTTON WAS PASSED THROUGH THE CORTEX AND THE TIGHTROPE BROKE ON THE SHORTENED STRANDS AND WOULD NOT TENSION COMPLETELY. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. THE CASE WAS COMPLETED BY USING ANOTHER IMPLANT. DELAY TO CASE 5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376979 ↗
• MalfunctionFeb 13, 2026Break

  ON 27-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-4551 SUTURELOC, AND AN AR-1588RTT2-IB FIBERTAG® TIGHTROPE FAILED DURING USE. THIS OCCURRED DURING AN ACL RECONSTRUCTION ON (B)(6) 2026 WHEN THE AR-4551 SUTURELOC ANCHOR PULLED THROUGH THE TIBIA. THE AR-1588RTT2-IB FIBERTAG® TIGHTROPES SUTURE BROKE AT THE BUTTON. ALL PORTIONS OF THE AR-4551 WERE REMOVED FROM THE PATIENT, WHILE THE SUTURE FROM THE AR-1588RTT2-IB WAS ATTACHED TO THE GRAFT AND REMAINS IN THE PATIENT, BUT THE BUTTON WAS REMOVED. THE PROCEDURE CONTINUED USING DEVICES FROM ANOTHER MANUFACTURER. THIS EVENT RESULTED IN APPROXIMATELY A 30-MINUTE DELAY, AND IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT HAD POOR BONE QUALITY, AND THE BONE WAS PREPPED WITH THE KIT'S DRILL. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24331999 ↗
• MalfunctionJan 6, 2026Material Rupture; Device Dislodged or Dislocated

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588RTT2-IB FIBERTAG TIGHTROPE II WITH INTERNALBRACE EXPERIENCED A FAILURE ON THE FEMORAL SIDE. AFTER DOCKING THE FEMORAL GRAFT AND COMPLETING THE LET PORTION OF THE PROCEDURE USING KNEE FIBERTAK IMPLANTS, THE SURGEON RETURNED TO PERFORM THE FINAL TENSIONING ON THE TIBIAL SIDE AND NOTED THAT THE GRAFT HAD PULLED OUT OF THE FEMORAL SOCKET. IT WAS OBSERVED THAT THE FEMORAL BUTTON WAS LOOSE, AND THE TIGHTROPE APPEARED TO BE RUPTURED. THE GRAFT WAS REMOVED, RE-PREPARED WITH NEW FEMORAL AND TIBIAL IMPLANTS, AND RE-IMPLANTED. THIS ADDED APPROXIMATELY 45¿60 MINUTES TO THE PROCEDURE; HOWEVER, THE CASE WAS COMPLETED WITHOUT COMPLICATIONS AND WITH GOOD FINAL GRAFT INTEGRITY AND FIXATION. THIS WAS DISCOVERED DURING A REVISION ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 22-DEC-2025: THE ISSUE OCCURRED INSIDE THE PATIENT AND WAS IDENTIFIED AFTER COMPLETION OF TIBIAL TENSIONING DURING A REVISION ACL RECONSTRUCTION PROCEDURE. FOLLOWING THE FAILURE OF THE TIGHTROPE AND BUTTON, THEY WERE REMOVED FROM THE PATIENT PRIOR TO PROCEEDING WITH NEW IMPLANTS. THE CASE WAS COMPLETED USING A

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974970 ↗
• MalfunctionAug 26, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 08/28/2025: THE LOT NUMBER FOR THE AR-1588RTT2-IB FIBERTAG TIGHTROPE II USED WAS LOT 15428786.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22895867 ↗
• MalfunctionAug 26, 2025Break; Break

  ON 08/06/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-15 ON 08/06/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1588RTT2-IB FIBERTAG TIGHTROPE II IMPLANT BROKE DURING FINAL TENSIONING ON THE FEMUR. THE CASE WAS COMPLETED, AND NO ADDITIONAL DETAILS WERE PROVIDED. THIS ISSUE WAS DISCOVERED DURING A QUAD ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 08/14/2025: THE BUTTON WAS LEFT IN THE PATIENT, AS IT STILL HAD THE IB SUTURES ATTACHED, AND THEY WANTED TO PRESERVE THE IB FOR THIS PATIENT. ONLY THE TIGHTROPE SUTURE WAS REMOVED. AN AR-1588BTB-2J TIGHTROPE II BTB WAS UTILIZED AND THREADED THROUGH THE BROKEN LIMB OF THE QUAD TIGHTROPE. IT WAS THEN SHUTTLED INTO THE FIBERTAK LOOP WHILE THE GRAFT REMAINED IN THE FEMORAL AND TIBIAL SOCKETS TO COMPLETE THE CASE. THEY USED A FLIPCUTTER FOR BONE PREPARATION, AND BONE QUALITY WAS ASSESSED AS NORMAL. THE PROCEDURE REQUIRED AN ADDITIONAL 20 MINUTES, DURING WHICH EXTRA ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED DURING OR FOLLOWING THE SURGERY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22895015 ↗
• MalfunctionAug 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 7/18/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1588RTT2-IB FIBERTAG TIGHTROPE II TIGHTROPE FRAYED AND EVENTUALLY DETACHED FROM THE GRAFT. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 07/24/2025: DURING AN ACL RECONSTRUCTION PROCEDURE ON 07/17/2025, THE AR-1588RTT2 FIBERTAG TIGHTROPE II IMPLANT BROKE INSIDE THE PATIENT. ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT AR-1588RTT2 DEVICE, RESULTING IN A BRIEF DELAY OF APPROXIMATELY FIVE MINUTES. NO ADDITIONAL ANESTHESIA WAS REQUIRED. A NON-ARTHREX PRODUCT WAS USED TO PREPARE THE BONE SOCKET FOR IMPLANT INSERTION. THE PATIENT'S BONE QUALITY WAS ASSESSED AS "GOOD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786482 ↗
• MalfunctionAug 11, 2025Break; Break

  ON 07/23/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1588RTT2-IB FIBERTAG TIGHTROPE II IMPLANT HAD THE TIGHTROPE BREAK DURING BASIC PASSAGE. A REPLACEMENT AR-1588RTT2-IB FIBERTAG TIGHTROPE II IMPLANT DEVICE WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A KNEE SCOPE WITH ACL PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 07/30/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22771975 ↗
• MalfunctionAug 11, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  ADDITIONAL INFORMATION WAS RECEIVED ON 07/31/2025: THE BROKEN IMPLANT WAS RETRIEVED FROM THE PATIENT. THERE WAS A 15-MINUTE DELAY, WITH AN ADDITIONAL 15 MINUTES OF ANESTHESIA ADMINISTERED TO THE PATIENT. NO ADVERSE EFFECTS WERE REPORTED ON OR AFTER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22771837 ↗
• MalfunctionAug 1, 2025Material Frayed; Material Frayed

  ON 07/14/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1588RTT2-IB FIBERTAG TIGHTROPE II IMPLANT FAILED DURING USE DUE TO AN ISSUE WITHIN THE FIBERTAPE LOOP ATTACHED TO THE GRAFT, WHERE THE SURGEON LOST THE ABILITY TO TENSION THE GRAFT. FRAYING OF THE IMPLANT WAS OBSERVED AND WHEN CUT OUT OF THE PATIENT (SEE PHOTO ATTACHMENT). THE CASE WAS COMPLETED USING A BTB TIGHTROPE AS A BAILOUT TECHNIQUE, ALONG WITH AN INTERFERENCE SCREW. THE EVENT RESULTED IN OVER 30 MINUTES OF ADDITIONAL OPERATING ROOM TIME. THIS WAS DISCOVERED DURING AN ALLOGRAFT ACHILLES FOR PCL PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 07/25/2025: THE CASE ADDED 20-25 MINUTES OF ANESTHESIA. AN AR-1588BTB-IB TIGHTROPE II BTB AND AN AR-4030C-10 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW WERE USED TO COMPLETE THE CASE, AND THE SURGEON WAS SATISFIED WITH THE OUTCOME. NO ADVERSE EFFECTS REPORTED ON OR AFTER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22688979 ↗
• MalfunctionJul 28, 2025Break; Break

  ON 07/07/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1588RTT2-IB FIBERTAG TIGHTROPE II IMPLANT FOR THE INTERNALBRACE TECHNIQUE EXPERIENCED AN ISSUE WITH THE WHITE LOOP ATTACHED TO THE GRAFT BREAKING UPON TENSIONING INSIDE THE PATIENT. THE CASE WAS COMPLETED BY REMOVING THE BROKEN SUTURE AND THE GRAFT FROM THE PATIENT. A REPLACEMENT AR-1588RTT2-IB FIBERTAG TIGHTROPE II IMPLANT FROM THE SAME LOT WAS USED WITHOUT ISSUES. THERE WAS A 40-MINUTE CASE DELAY, AND A LARGER INCISION WAS MADE TO RETRIEVE THE BROKEN IMPLANT. IT IS UNCERTAIN IF ADDED ANESTHESIA WAS ADMINISTERED TO THE PATIENT. THIS WAS DISCOVERED DURING A QUAD TENDON ACL PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637940 ↗
• MalfunctionJul 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 6/18/2025 IT WAS REPORTED BY A SALES REPRESENTATIVE, VIA EMAIL, THAT AN AR-1588RTT2-IB FIBERTAG TIGHTROPE II SUTURES RIPPED DURING USE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION ATTEMPTS HAVE BEEN MADE WITH NO RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 22506038 ↗
• MalfunctionJun 26, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE SUTURE SNAPPED AT THE POINT OF THE LOCKING MECHANISM WHEN TENSIONING THE GRAFT INTO THE FEMORAL SOCKET. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A SCREW IN THE FEMORAL CHONDYLE TO SECIRE THE GRAFT. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340510 ↗
• MalfunctionJun 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 5/27/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1588RTT2-IB FIBERTAG TIGHTROPE II IMPLANT HAD AN ISSUE DURING A DISTAL BICEPS PROCEDURE ON (B)(6) 2025. WHEN THE SURGEON WAS USING THE DEVICE, THE NEEDLE FELL OFF IMMEDIATELY WHEN HE WAS TRYING TO PUT THE NEEDLE THROUGH THE TENDON. THIS DID NOT OCCUR ON THE BACK TABLE, BUT INSIDE THE PATIENT. THE SURGEON REMOVED THE IMPLANT AND THE NEEDLE FROM THE PATIENT IN ONE PIECE; NOTHING BROKE INSIDE THE PATIENT, AND THERE WAS NO HARM. THE COMPLAINT DEVICE WAS DISCARDED, AND NO PICTURES WERE TAKEN. ANOTHER AR-1588RTT2-IB FIBERTAG TIGHTROPE II IMPLANT WITH LOT NUMBER 15173844 WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A 3-MINUTE CASE DELAY, AND ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284421 ↗
• MalfunctionJun 18, 2025Break; Break

  ON 05/22/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588RTT2-IB TIGHTROPE FINGERTRAP OF THE TIGHTROPE BROKE WHEN UNDER TENSION. THIS OCCURRED DURING USE IN A ALLOGRAFT CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282732 ↗
• MalfunctionJun 16, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ALL-INSIDE QUADRICEPS ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE SNAPPED ON THE FEMORAL SIDE WHEN TENSIONING THE GRAFT. NO PIECES WERE BROKEN OFF INSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY BY USING A DIFFERENT TECHNIQUE: A SCREW WAS USED FOR THE FEMORAL CONDYLE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213591 ↗
• MalfunctionJun 16, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ALL INSIDE QUADS ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE SNAPPED. THE LOCKING MECHANISM SNAPPED ON THE TIBIAL SIDE WHEN TENSIONING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. BECAUSE THE TIGHTROPE SNAPPED AND THE LOCKING MECHANISM DIDN'T WORK, THE SURGEON USED AN INTERFERENCE SCREW. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22210376 ↗
• MalfunctionMay 12, 2025Break; Break

  ON 04/16/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588RTT2-IB FIBERTAG TIGHTROPE II IMPLANT FOR THE INTERNALBRACE TECHNIQUE BROKE DURING BASIC PASSAGE. A NEW TIGHTROPE WAS OPENED, AND THE CASE WAS COMPLETED. NO PATIENT WAS HARMED. THIS WAS DISCOVERED DURING A KNEE SCOPE WITH ACL PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED IF THIS OCCURRED BEFORE USE ON THE BACK TABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005361 ↗
• MalfunctionMay 12, 2025Break; Break

  ON 04/16/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588RTT2-IB FIBERTAG TIGHTROPE II IMPLANT FOR THE INTERNAL BRACE TECHNIQUE BROKE DURING BASIC PASSAGE. A NEW TIGHTROPE WAS OPENED, AND THE CASE WAS COMPLETED. NO PATIENT WAS HARMED. THIS WAS DISCOVERED DURING A KNEE SCOPE WITH ACL PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED IF THIS OCCURRED BEFORE USE ON THE BACK TABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005208 ↗
• MalfunctionMay 5, 2025Break; Break

  ON 04/23/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1588RTT2-IB FIBERTAG TIGHTROPE II IMPLANT AND AN AR-1288RTT2-FC FIBERTAG TIGHTROPE II BROKE DURING THE TENSIONING PROCESS AT THE CORTICAL BUTTON. EVERYTHING WAS REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING AN AR-1288QIS-100 QUADLINK IMPLANT SYSTEM. THE CASE HAD A DELAY OF MORE THAN ONE HOUR BUT LESS THAN TWO HOURS. IT IS UNKNOWN THE AMOUNT OF ADDED ANESTHESIA ADMINISTERED TO THE PATIENT. NO ADVERSE EFFECTS WERE REPORTED ON OR AFTER THE SURGERY. THIS WAS DISCOVERED DURING A PRIMARY ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961602 ↗
• 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 21911148 ↗
• InjuryApr 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 04/21/2025: THE INFECTION HAS BEEN IDENTIFIED AS FINEGOLDIA MAGNA, THE PRIMARY CAUSE, WITH ENTEROBACTER CLOACAE DETECTED ONLY IN THE ENRICHMENT BROTH. THERE WAS NO INDICATION THAT THE IMPLANTS CONTRIBUTED TO THE INFECTION, AND THEIR STERILITY WAS NOT IN QUESTION. AFTER THREE WASHOUTS, THE SURGEON DETERMINED THAT REMOVING ALL IMPLANTS FROM THE KNEE WAS THE BEST COURSE OF ACTION. THE IMPLANTS WERE REMOVED LAST WEEK, AND THE PATIENT IS NOW HOME, RECOVERING WITH IV AND ORAL ANTIBIOTICS.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 21881258 ↗
• MalfunctionApr 22, 2025Break; Break

  ON 3/26/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-1588RTT2-IB FIBERTAG TIGHTROPE II BROKE DURING BASIC PASSAGE. THE CASE WAS COMPLETED USING A NEW TIGHTROPE. THIS WAS DISCOVERED DURING A KNEE SCOPE WITH ACL PROCEDURE ON (B)(6) 2025.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 21881021 ↗
• MalfunctionApr 21, 2025Break; Break

  ON 04/04/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1588RTT2 FIBERTAG® TIGHTROPE® II IMPLANT SUTURE SHEATH THAT ENTERS THE BUTTON DISASSEMBLED IT FELL APART. TWO AR-1204FF FLIPCUTTER®III DRILLS FAILED ONE OF THE MECHANISMS THAT OPENS AND CLOSES BROKE FOLLOWING THE PROPER TECHNIQUE. THE SECOND ONE'S EXTERNAL SHAFT BROKE. THIS OCCURRED DURING A CASE, ALL FRAGMENTS WERE RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 21876483 ↗