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Arthrex® AR-1588TNRecalls & reported problems

Arthrex, Inc. · TIGHTROPE, ABS, IMPLANT · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
23
Deaths reported
0
Injuries reported
7
Recalls naming it
0

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00888867019706), received between Jul 7, 2017 and Sep 21, 2026 — classified as 7 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 2 reportsMar 2024: 1 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break9
  • Material Split, Cut or Torn3
  • Use of Device Problem3
  • Material Separation2
  • Appropriate Device Problem Term/Code Not Available1
  • Defective Device1
  • Detachment of Device or Device Component1
  • Device Operates Differently Than Expected1

Patient problems

  • No Clinical Signs, Symptoms or Conditions15
  • Failure of Implant3
  • No Known Impact Or Consequence To Patient2
  • Complaint, Ill-Defined1
  • Device Embedded In Tissue or Plaque1
  • Injury1
  • Insufficient Information1

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 21, 2026Break

    On 7th September 2026, it was reported by a Distributor via an Email that for 1 unit of AR-1588TN and 1 unit of AR-3632:The AR-1588TN broke during loop shortening steps on the tendon site while the AR-3632 was pulled out while fixing the ALL.This was detected during an ACL+ALL reconstruction procedure on (b)(6)2026. The procedure was completed successfully by using additional AR-1588TN and AR-3632. There was no patient harm.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50841611 ↗
  • MalfunctionMay 5, 2026Material Split, Cut or Torn

    IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE TORE DURING THE GRAFT 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 25084574 ↗
  • MalfunctionMar 23, 2026Material Split, Cut or Torn

    IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIGHTROPE WAS TORN. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY USING A DIFFERENT TECHNIQUE: THE BUTTON TECHNIQUE WAS REPLACED BY THE SCREW TECHNIQUE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24662596 ↗
  • MalfunctionFeb 10, 2026Break

    IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION PROCEDURE ONE OF THE SUTURES BROKE DURING IMPLANTATION, WHICH PREVENTED PROPER STABILIZATION 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 24302855 ↗
  • MalfunctionDec 22, 2025Positioning Failure; Positioning Failure

    IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE LOOP OF THE DEVICE DID NOT LOCK. 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 23863866 ↗
  • MalfunctionApr 18, 2025Break; Break

    ON 3RD APRIL 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-1588TN, TIGHTROPE®, NO BUTTON, THE TIGHTROPE BROKE WHILE USING AR-1588TN TO REINFORCE. THIS WAS DETECTED DURING A RECONSTRUCTION OF THE POSTERIOR CRUCIATE LIGAMENT OF THE KNEE SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1588TN. THERE WAS NO PATIENT HARM, AND NO SECONDARY PROCEDURE WAS NEEDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21864923 ↗
  • MalfunctionDec 26, 2024Use of Device Problem; Use of Device Problem

    IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY WHEN TRYING TO FIX THE IMPLANT THE DEVICE DID NOT WORK PROPERLY, BECAUSE THE LOOPS DID NOT TWIST CORRECTLY. 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 21018378 ↗
  • MalfunctionJun 10, 2024Break; Break

    IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT GRAFT LINK SURGERY DURING THE INSERTION OF THE GRAFT, THE TIGTROPE SUTURE OF THE DEVICE TORE. THEREFORE, THE GRAFT HAD TO BE COMPLETELY CREATED FROM THE START. ACCORDING TO THE SURGEON 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 19500051 ↗
  • MalfunctionApr 18, 2024Break; Break

    ON 08/29/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1588TN TIGHTROPE BROKE WHEN SURGEON WAS TENSIONING. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19132968 ↗
  • MalfunctionMar 8, 2024Defective Device; Defective Device

    IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIGHTROPE COULD NOT BE TIGHTENED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 18869770 ↗
  • MalfunctionFeb 15, 2024Use of Device Problem; Use of Device Problem

    IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REFIXATION SURGERY THE LOCKING MECHANISM COULD NOT BE TIGHTENED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-1370C). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18710391 ↗
  • InjuryFeb 5, 2024Material Separation; Material Separation

    ON 17TH DECEMBER 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588RTT ACL FIBERTAG TIGHTROPE POTENTIALLY UNTHREADED FROM LOCKING SOCK WHEN UNTANGLED. THIS WAS DETECTED ON 28TH NOVEMBER 2023 DURING A REVISION ACL WITH QUADS GRAFT PROCEDURE. 8TH JAN 2024 - THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE TIGHTROPE WAS UNSTITCHED FROM THE QUAD GRAFT AND RE-STITCHED WITH A NEW IMPLANT. 12TH JAN 2024 - THE FOLLOWING PART NUMBERS WERE USED IN THE ORIGINAL ACL PROCEDURE: AR-1588RT, AR-1588TN AND AR-1588TB-4.

    Patient problems: Failure of Implant

    MAUDE report 18639741 ↗
  • MalfunctionDec 28, 2023Use of Device Problem; Use of Device Problem

    IT WAS REPORTED THAT THE LOOP OF THE DEVICE IS DAMAGED DURING A RECONSTRUCTION SURGERY AND THE DEVICE DIDN`T LOCK UP WHEN PINCHED. NO PART OF THE DEVICE BROKE INSIDE THE PATIENT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME 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 18415645 ↗
  • MalfunctionSep 13, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

    IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE TORE WHEN TIGHTENING THE LOOP. 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: Failure of Implant; No Clinical Signs, Symptoms or Conditions

    MAUDE report 17737123 ↗
  • MalfunctionAug 29, 2023Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIGHTROPE SEPARATED. 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 (B)(6) 2023 NEN: FURTHER INFORMATION WAS PROVIDED AND REVEALED THAT THE SUTURE KNOT HAS COME LOOSE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17645647 ↗
  • InjurySep 14, 2021Loose or Intermittent Connection

    IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WHILE TIGHTENING THE LOOP COULD NOT BE KNOTTED. THE SURGEON SWITCHED TO A FIXATION WITH A VILAGRO SCREW TO FINISH THE PROCEDURE SUCCESSFULLY. ON 30-AUG-2021 UPDATE DW: FURTHER INFORMATION WERE PROVIDED THAT THE GRAFT WAS PREPARED IN A "GRAFT LINK" MANNER WITH TIGHTROPE RT ON THE FEMORAL AND TIGHTROPE ABS ON THE TIBIAL SIDE. THE TIBIAL TUNNEL WAS DRILLED THROUGH COMPLETELY AND THE SURGEON PLACED GRAFT IN THE FEM. TUNNEL AND FIXATED IT ON CORTEX. PROCEDURE WAS CONTINUED WITH FIXATING GRAFT ON THE TIBIAL SIDE BUT WHEN THE ABS TIGHTROPE LOOP SHOULD LOCK OVER THE ABS BUTTON THE SYSTEM DIDN'T LOCK AND THE LOOP STAYED LOOSE. AS THE FIXATION DID NOT WORK THE SURGEON PLACED ADDITIONAL INTERFERENCE SCREW IN TIBIAL TUNNEL AND FIXATED THE GRAFT. THE SURGEON REMOVED THE ABS BUTTON BUT REMAINED THE TIGHTROPE INSIDE THE PATIENT.

    Patient problems: Failure of Implant

    MAUDE report 12467743 ↗
  • MalfunctionJul 20, 2021Break

    STANDARD FOUR STRAND 8.5MM GRAFTLINK GRAFT PREPARED BY SURGEON. AFTER CINCHING THE GRAFT INTO THE FEMORAL TUNNEL. THE AR-1588TB-4 WAS PLACED ON THE AR-1588TN AND CINCHED DOWN. AS FINAL CINCHING WAS HAPPENING USING THE TENSIONING HANDLES THE AR-1588TN BROKE AND PULLED OUT FROM THE GRAFT. THE SURGEON COMPLETED THE FIXATION USING THE FIBERLOOP SUTURES FROM THE GRAFTLINK TIED OVER THE BUTTON. THERE WAS NO EVIDENCE THAT THE AR-1588TN HAD BEEN CUT OR ABRADED BY ANYTHING SHARP IN THE PREPARATION OF THE GRAFT.

    Patient problems: Insufficient Information

    MAUDE report 12196115 ↗
  • MalfunctionJun 1, 2021Break

    IT WAS REPORTED THAT DURING AN ACLR SURGERY WHILE PULLING ON THE DEVICE THE LOOP BROKE OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 11911938 ↗
  • InjuryOct 5, 2020Device Slipped; Unraveled Material; Unstable

    AN ARTHREX EMPLOYEE HAS REPORTED THAT DURING AN ALL-INSIDE GRAFTLINK ANTERIOR AND POSTERIOR CRUCIATE LIGAMENT SURGERY THE ABS TIGHTROPE IMPLANT CAME 'UNDONE' WITH TWO SEPARATE IMPLANTS DURING ONE PROCEDURE. THE IMPLANTS BOTH FAILED THROUGH THE SAME METHOD. ONE OF THE WHITE SUTURES USED TO TOGGLE AND REDUCE THE LOOP OF THE ABS CAME OUT OF THE LOCKING CONSTRUCT OF THE TIGHTROPE BACKWARDS SO THE LOOP UNRAEALLED AND BECAME UNUSABLE. THIS OCCURRED DURING GRAFT PREPARATION SO THERE WAS NO MAJOR ISSUE THE FAULT IMPLANT WAS JUST DISPOSED OF AND A NEW ABS IMPLANTS OPENED. HOWEVER THE SECOND TIME THIS HAPPENED WAS WHILST THE IMPLANT WAS BEING SHUTTLED DOWN THE TIBIAL SOCKET FOR THE POSTERIOR CURCIATE LIGAMENT SO CAUSED DELAY IN SURGERY AS THE GRAFT HAD TO BE RETRIEVED FROM THE JOINT AND A BTB TIGHTROPE AR-1588BTB WAS USED TO GET INSIDE THE ALREADY PREPARED GRAFTLINK TO FINISH THE SURGERY SUCCESSFULLY. *** UPDATE 15-SEP-2020 FURTHER INFORMATION WAS PROVIDED THAT THE SURGERY TIME WAS EXTENDED BY APPROXIMATELY 20 MINUTES.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10631101 ↗
  • InjuryOct 5, 2020Material Separation; Therapeutic or Diagnostic Output Failure

    AN ARTHREX EMPLOYEE HAS REPORTED THAT DURING AN ALL-INSIDE GRAFTLINK ANTERIOR AND POSTERIOR CRUCIATE LIGAMENT SURGERY THE ABS TIGHTROPE IMPLANT CAME 'UNDONE' WITH TWO SEPARATE IMPLANTS DURING ONE PROCEDURE. THE IMPLANTS BOTH FAILED THROUGH THE SAME METHOD. ONE OF THE WHITE SUTURES USED TO TOGGLE AND REDUCE THE LOOP OF THE ABS CAME OUT OF THE LOCKING CONSTRUCT OF THE TIGHTROPE BACKWARDS SO THE LOOP UNRAVELLED AND BECAME UNUSABLE. THIS OCCURRED DURING GRAFT PREPARATION SO THERE WAS NO MAJOR ISSUE THE FAULT IMPLANT WAS JUST DISPOSED OF AND A NEW ABS IMPLANTS OPENED. HOWEVER THE SECOND TIME THIS HAPPENED WAS WHILST THE IMPLANT WAS BEING SHUTTLED DOWN THE TIBIAL SOCKET FOR THE POSTERIOR CRUCIATE LIGAMENT SO CAUSED DELAY IN SURGERY AS THE GRAFT HAD TO BE RETRIEVED FROM THE JOINT AND A BTB TIGHTROPE AR-1588BTB WAS USED TO GET INSIDE THE ALREADY PREPARED GRAFTLINK TO FINISH THE SURGERY SUCCESSFULLY. UPDATE 15-SEP-2020: FURTHER INFORMATION WAS PROVIDED THAT THE SURGERY TIME WAS EXTENDED BY APPROXIMATELY 20 MINUTES.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10631067 ↗
  • InjuryJan 27, 2020Break; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE FOLLOWING CLINICAL EVENT INFORMATION WAS PROVIDED IN A TGA CLOSURE LETTER: PATIENT UNDERWENT A SHOULDER SURGERY ON JULY 1, 2019 USING X4 ARTHREX TIGHTROPE ABS IMPLANTS, AR-1588TN, (ARTG ID# (B)(4)). THE PATIENT WAS TOLD BY HIS ORTHOPEDIC SURGEON EACH ONE HAS 1000 NEWTONS STRENGTH (102 KG FORCE) BEING 408 KG FORCE TOTAL TO BREAK. PATIENT STATES HE KNOWS EVERYTHING LOOKED WELL THE MORNING AFTER SURGERY BECAUSE X-RAYS WERE TAKEN. AFTER SEVERAL WEEKS WHEN HE CAME OUT OF SLING HE NOTICED THE CLAVICLE STILL STUCK UP LIKE BEFORE SURGERY. HE WENT TO HIS GENERAL PRACTITIONER WHO SENT HIM FOR AN X-RAY ON (B)(6) 2019 WHICH SHOWED SEPARATION WITH ANCHORS STILL PROPERLY PLACED. THE PATIENT THEN SAW HIS ORTHOPEDIC SURGEON WHO CONFIRMED IT LOOKS LIKE THE PRODUCT HAS FAILED. THE PATIENT HAS A REVISION SURGERY SCHEDULED FOR REPLACEMENT OF THE PRODUCT. ADDITIONAL INFORMATION PROVIDED 9/6/2019- THE REVISION SURGERY IS SCHEDULED FOR (B)(6) 2019. THE DOGBONE UNDER THE CLAVICLE WILL REMAIN IN THE PATIENT AS IT IS TOO DANGEROUS TO REMOVE. THE PATIENT DID NOT SUFFER ANY KIND OF POST-OP TRAUMA. ADDITIONAL INFORMATION PROVIDED 1/7/2020- THE PRODUCT SPECIALIST SPOKE TO THE HOSPITAL A

    Patient problems: Injury

    MAUDE report 9631335 ↗
  • InjuryAug 21, 2019Break; Material Fragmentation

    IT WAS REPORTED DURING A REVISION ACL PROCEDURE, UPON INSERTING THE FEMORAL AR-4020C-07 FAST THREAD BIOCOMPATIBLE INTERFERENCE SCREW (LOT: 10248522) THE SCREW CRUMBLED INTO MULTIPLE PIECES AFTER ONE AND A HALF TURNS. THE REP CONFIRMED ALL BROKEN PIECES OF THE SCREW WERE RETRIEVED BY USING A GRASPER. A SECOND AR-4020C-07 FROM A DIFFERENT LOT (LOT: 10262903) WAS BROUGHT IN. UPON INSERTING, THE SCREW BROKE INTO TWO HALVES AFTER ONE AND A HALF TURNS. THE REP CONFIRMED ALL PIECES WERE FULLY REMOVED BY USING A GRASPER. ANOTHER MANUFACTURER'S SCREW WAS BROUGHT IN AND USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. ONLY ONE SCREW IS AVAILABLE TO RETURN (LOT: 10262903) AS THE OTHER SCREW WAS DISCARDED. THE REP STATED THE REVISION TOOK PLACE DUE THE PATIENT RE-TEARING THEIR ACL. THE ORIGINAL IMPLANTED ARTHREX TIGHTROPE AND FIBERWIRE WERE EXPLANTED DURING THE REVISION. ADDITIONAL INFORMATION RECEIVED ON 08/01/2019: THE REP CONFIRMED THE REVISION WAS DUE TO RE-INJURY AND WAS NOT IMPLANT RELATED. THE PRIMARY PROCEDURE WAS A QUAD TENDON AUTOGRAFT, SOFT TISSUE. THE PRIMARY AND REVISION PROCEDURE WERE PERFORMED BY THE SAME SURGEON AND TOOK PLACE AT THE SAME FACILITY. THE SURGEON REVISED WITH

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 8917047 ↗
  • InjuryJul 7, 2017Device Operates Differently Than Expected; Physical Property Issue

    IT WAS ORIGINALLY REPORTED THAT AFTER TIGHTENING THE TIBIAL SIDE WHILE EXTENDING THE PATIENT LEG, THE LOOP CUT INTO TWO PARTS. AFTER FINISHING THE CASE THE THREADS HOLDING THE BUTTON RIPPED AND THE SURGEON WAS STUCK WITH A SHORT GRAFT FOR ALMOST TWO HOURS TRYING TO CUT THE FEMORAL BUTTON SO HE CAN RELEASE THE GRAFT AND REPEAT THE CASE. THE ACL RECONSTRUCTION USING ALL INSIDE TECHNIQUE WAS PERFORMED. AFTER THAT THE SURGEON USED A DIFFERENT DEVICE WITH PART NO.: AR-1588RT. ADDITIONAL INFORMATION OBTAINED 8 JUNE 2017: THE SURGEON PREPARED THE GRAFT USING AN RT TIGHTROPE AND ABS TIGHTROPE FOR THE TIBIA. GRAFT WAS A SIZE 11. BOTH TENDONS WERE HARVESTED. INSTEAD OF A FLIP CUTTER SURGEON USED AND AR-1595T TO OPEN THE EYELET DRILL PIN FOR THE FEMUR AND THE TIBIAL CORTEX WAS BLOWN OUT WITH A DRILL BIT. AFTER PASSING THE GRAFT AND SHORTENING THE FEMORAL TIGHTROPE SURGEON BEGAN SHORTENING THE TIBIAL ABS TIGHTROPE. ALL LOOKED FINE UNTIL SURGEON STARTED TO PROBE THE GRAFT WHICH WAS LAX. SURGEON WENT BACK TO THE TIBIAL TO RETIGHTEN THE TIGHTROPE AND IT WAS FOUND TORN. THE GRAFT WAS SHORT INSIDE THE TUNNEL SO SURGEON CUT THE FEMORAL BUTTON TO RELEASE THE WHOLE GRAFT WHICH TOOK AN HOUR. THE SAME G

    Patient problems: Complaint, Ill-Defined

    MAUDE report 6692691 ↗

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