Arthrex® AR-1588BTB-2JRecalls & reported problems

Summary

The FDA's MAUDE database contains 123 adverse event reports that list this exact device (DI 00888867319660), received between Nov 16, 2021 and Sep 23, 2026 — classified as 1 injury, 122 malfunctions.

The most frequently reported specific device problem is “Break” (41 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 123 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Component Missing

  On 09-Sep-2026, an Arthrex subsidiary employee reported via email that an AR-1588BTB-2J TightRope II BTB with Deploying Suture experienced an issue during an ACL reconstruction using the BTB technique performed on (b)(6)2026. While advancing the graft, it was not progressing properly through the tunnel. Evaluation at the tibial level revealed that the graft was trapped and not passing as intended. The implant was removed from the surgical field for inspection, at which time it was observed that one of the traction sutures was missing. A new implant was used, and upon reinsertion, the graft advanced properly through the tunnel. The procedure was completed successfully using an alternate implant. No additional anesthesia was administered. The patient outcome was not reported.

  Patient problems: Insufficient Information

  MAUDE report 50868739 ↗
• MalfunctionSep 17, 2026Break

  It was reported that during a knee surgery the suture broke and came loose. A second unit from a different lot was used, resulting in the same problem. All 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 third 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 50801049 ↗
• MalfunctionSep 17, 2026Break

  It was reported that during a knee surgery the suture broke and came loose. A second unit from a different lot was used, resulting in the same problem. All 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 third 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 50800810 ↗
• MalfunctionAug 6, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50157119 ↗
• MalfunctionApr 11, 2026Break

  IT WAS REPORTED THAT DURING THE RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT, THE TIGHTROPE SNAPPED WHILE BEING TIGHTENED. 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 24846258 ↗
• MalfunctionFeb 24, 2026Failure to Advance

  ON 06-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1588BTB-2J TIGHTROPE II BTB WITH DEPLOYING SUTURE EXPERIENCED AN ISSUE DURING USE. WHEN ATTEMPTING TO PASS THE SUTURE THROUGH THE TIGHTROPE MECHANISM, THE TAPE BALLED UP WITHIN THE BUTTON AND COULD NOT BE ADVANCED AS INTENDED. THE ISSUE OCCURRED IN A PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429662 ↗
• MalfunctionFeb 4, 2026Break

  ON 14-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1588BTB-2J TIGHTROPE II BTB SUTURE BROKE DURING TENSIONING AFTER IMPLANTATION. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION WITH GRAFTLINK ALLOGRAFT PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 20-JAN-2026: ALL FRAGMENTS WERE RETRIEVED. THE SUTURE FAILED DURING FINAL TENSIONING, AFTER THE GRAFT HAD BEEN CYCLED THROUGH RANGE OF MOTION AND THE SURGEON PROCEEDED TO RE-TENSION FOR FINAL FIXATION. THE SAME PRODUCT PART NUMBER WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS EXTENDED BY APPROXIMATELY 30-45 MINUTES, AND THE PATIENT REQUIRED AN ADDITIONAL 30-45 MINUTES OF ANESTHESIA DUE TO THE DELAY OCCURRING AT THE FINAL STEP OF THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258343 ↗
• MalfunctionFeb 2, 2026Material Frayed

  ON 2ND FEBRUARY 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1588BTB-2J, TIGHTROPE® II BTB, WITH DEPLOYING SUTURE, THE WHITE TIGHTROPE SUTURE WAS NOT SHUTTLING THROUGH THE RT BUTTON. THE SUTURES WERE EXTREMELY FRAYED AND MADE PASSING VERY DIFFICULT. THIS WAS DETECTED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A NEW UNIT WAS OPENED.

  Patient problems: Insufficient Information

  MAUDE report 24232991 ↗
• MalfunctionDec 11, 2025Break; Break

  ON (B)(6) 2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT THREE TIGHTROPE DEVICES, AR-1588RT-2J TIGHTROPE II RT AND TWO AR-1588BTB-2J TIGHTROPE II BTB, WERE INVOLVED IN ISSUES DURING A HAMSTRING LCA RECONSTRUCTION PROCEDURE ON (B)(6) 2025. AN AR-1588RT-2J TIGHTROPE II RT (LOT 15412617) AND AN AR-1588BTB-2J TIGHTROPE II BTB (LOT 15446881) EXPERIENCED KNOTLESS MECHANISM FAILURE DURING GRAFT INSERTION INTO A 4 MM FEMORAL TUNNEL, PREVENTING COMPLETION OF THE PRIMARY FUNCTION DESPITE FOLLOWING THE RECOMMENDED TECHNIQUE AND WITHOUT EXCESSIVE FORCE. THE THIRD DEVICE, AR-1588BTB-2J TIGHTROPE II BTB (LOT 15462879), EXPERIENCED A SUTURE JAM IN THE KNOTLESS MECHANISM DURING CONVERSION STEP 3 OF THE BTB TIGHTROPE TECHNIQUE. THE STRAIGHT LIMB SUTURE (2) BECAME STUCK, PREVENTING SYSTEM CONVERSION. ADDITIONAL INFORMATION WAS RECEIVED ON 12/01/2025: FOR THE AR-1588RT-2J TIGHTROPE II RT (LOT 15412617) AND THE AR-1588BTB-2J TIGHTROPE II BTB (LOT 15446881), THE FAILURE OCCURRED AFTER THE BUTTON WAS FLIPPED WHILE PULLING THE WHITE SUTURES TO BRING THE GRAFT INTO THE TUNNEL. THE FINAL TENSION HAS NOT YET BEEN ACHIEVED. FOR THE THIRD DEVICE, AR-1588BTB-2J TIGHTROPE II BTB (LOT 15462879), THE STRAIGHT LIMB S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777592 ↗
• MalfunctionDec 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT THREE TIGHTROPE DEVICES, AR-1588RT-2J TIGHTROPE II RT AND TWO AR-1588BTB-2J TIGHTROPE II BTB, WERE INVOLVED IN ISSUES DURING A HAMSTRING LCA RECONSTRUCTION PROCEDURE ON (B)(6) 2025. AN AR-1588RT-2J TIGHTROPE II RT (LOT 15412617) AND AN AR-1588BTB-2J TIGHTROPE II BTB (LOT 15446881) EXPERIENCED KNOTLESS MECHANISM FAILURE DURING GRAFT INSERTION INTO A 4 MM FEMORAL TUNNEL, PREVENTING COMPLETION OF THE PRIMARY FUNCTION DESPITE FOLLOWING THE RECOMMENDED TECHNIQUE AND WITHOUT EXCESSIVE FORCE. THE THIRD DEVICE, AR-1588BTB-2J TIGHTROPE II BTB (LOT 15462879), EXPERIENCED A SUTURE JAM IN THE KNOTLESS MECHANISM DURING CONVERSION STEP 3 OF THE BTB TIGHTROPE TECHNIQUE. THE STRAIGHT LIMB SUTURE (2) BECAME STUCK, PREVENTING SYSTEM CONVERSION. ADDITIONAL INFORMATION WAS RECEIVED ON 12/01/2025: FOR THE AR-1588RT-2J TIGHTROPE II RT (LOT 15412617) AND THE AR-1588BTB-2J TIGHTROPE II BTB (LOT 15446881), THE FAILURE OCCURRED AFTER THE BUTTON WAS FLIPPED WHILE PULLING THE WHITE SUTURES TO BRING THE GRAFT INTO THE TUNNEL. THE FINAL TENSION HAS NOT YET BEEN ACHIEVED. FOR THE THIRD DEVICE, AR-1588BTB-2J TIGHTROPE II BTB (LOT 15462879), THE STRAIGHT LIMB S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777500 ↗
• MalfunctionDec 9, 2025Positioning Failure; Positioning Failure

  ADDITIONAL INFORMATION: THIS ISSUE WAS DISCOVERED DURING AN ACLR PROCEDURE. IT IS UNCLEAR WHETHER THE SUSPENSION MECHANISM INITIALLY LOCKED AND THEN FAILED OR NEVER LOCKED, AS WELL AS WHETHER EXCESSIVE FORCE WAS APPLIED DURING GRAFT ADJUSTMENT OR MILKING MOTION. THERE WERE NO SIGNS OF DEVICE DAMAGE, SUCH AS FRAYED SUTURES. THE SURGERY WAS NOT DELAYED, AND NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED DURING OR FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23758816 ↗
• MalfunctionNov 25, 2025Positioning Failure; Failure to Advance; Positioning Failure; Failure to Advance

  ON 10/29/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588BTB-2J TIGHTROPE II BTB WOULDN¿T STAY CINCHED. THE IMPLANT WAS LEFT IN THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 11/11/2025: THE CASE WAS COMPLETED USING AN AR-4020C-09 FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW. THE SALES REPRESENTATIVE WAS UNABLE TO CONFIRM WHETHER THE CASE WAS DELAYED OR IF ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23647046 ↗
• MalfunctionAug 21, 2025Use of Device Problem; Use of Device Problem

  ON 08/05/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-1588BTB-2J CARD CONVERSION FAILED. THIS OCCURRED DURING AN ACL RECONSTRUCTION/ KNEE SCOPE THE BTB TIGHTROPE CARD CONVERSION FAILED. THE SURGEON PULLED THE WIRE LOOP THROUGH AND IT WAS NOT THREADED THROUGH THE METAL BUTTON. THEY OPENED A NEW BTB TIGHTROPE II TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 22859894 ↗
• MalfunctionAug 5, 2025Break; Break

  ON 17TH JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-1588BTB-2J, TIGHTROPE® II BTB, WITH DEPLOYING SUTURE, THE NITINOL WIRE BROKE WHILE PULLING IN THE SUTURE. THIS WAS DETECTED DURING AN ACL RECON REVISION WITH BTB GRAFT ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, ACL DONE IN PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720582 ↗
• MalfunctionAug 1, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 14TH JULY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN, AR-1588BTB-2J, TIGHTROPE® II BTB, WITH DEPLOYING SUTURE, THEY THREADED THE NO. 1 THREAD OF THE TIGHTROPE THROUGH THE BTB GRAFT, THREADED IT THROUGH ITSELF AND THEN THROUGH THE NITINOL SPLICING DEVICE, WHICH BROKE IN HALF WHEN DEPLOYED. THIS CAUSE SOME OF THE TIGHTROPE SUTURE TO SPLICE HALFWAY THROUGH ITSELF, WHICH THEN COULD NOT BE USED AS A TIGHTROPE, CAUSING IT TO BE FAULTY. THIS WAS DETECTED DURING USE IN AN ACL BTB PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY OPENED ANOTHER TIGHTROPE BTB WITHOUT INCIDENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22687697 ↗
• MalfunctionJun 30, 2025Break; Break

  ON 6/5/2025, IT WAS REPORTED VIA EMAIL BY A SALES REPRESENTATIVE THAT DURING AN ALLOGRAFT ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025, TWO AR-1588BTB-2J BTB TIGHTROPES FAILED IN THE SAME MANNER. WHILE THE FINAL TENSION WAS BEING APPLIED ON THE TIBIAL SIDE, THE TIGHTROPE BROKE AT THE FINGER TRAP NEAR THE BUTTON. AFTER THE INITIAL FAILURE, A SECOND BTB TIGHTROPE FROM THE SAME LOT WAS USED, BUT IT ALSO FAILED AT THE SAME LOCATION. THE SURGICAL TEAM CONFIRMED THERE WAS NO METAL INTERFERENCE OR SHARP OBJECT PRESENT FROM PRIOR PROCEDURES THAT COULD HAVE CONTRIBUTED TO THE BREAKAGE. TO COMPLETE THE CASE, THE REMAINING SUTURE THROUGH THE GRAFT WAS TIED OVER ONE OF THE BUTTONS AND REINFORCED USING A SECONDARY FIXATION KIT. THE CASE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED ON 6/20/2025: ALL THE BROKEN FRAGMENTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER AR-1588BTB-2J BTB TIGHTROPE. THE CASE EXPERIENCED A DELAY OF FORTY-FIVE MINUTES, DURING WHICH ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22357107 ↗
• MalfunctionJun 30, 2025Break; Break

  ON 6/5/2025, IT WAS REPORTED VIA EMAIL BY A SALES REPRESENTATIVE THAT DURING AN ALLOGRAFT ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025, TWO AR-1588BTB-2J BTB TIGHTROPES FAILED IN THE SAME MANNER. WHILE THE FINAL TENSION WAS BEING APPLIED ON THE TIBIAL SIDE, THE TIGHTROPE BROKE AT THE FINGER TRAP NEAR THE BUTTON. AFTER THE INITIAL FAILURE, A SECOND BTB TIGHTROPE FROM THE SAME LOT WAS USED, BUT IT ALSO FAILED AT THE SAME LOCATION. THE SURGICAL TEAM CONFIRMED THERE WAS NO METAL INTERFERENCE OR SHARP OBJECT PRESENT FROM PRIOR PROCEDURES THAT COULD HAVE CONTRIBUTED TO THE BREAKAGE. TO COMPLETE THE CASE, THE REMAINING SUTURE THROUGH THE GRAFT WAS TIED OVER ONE OF THE BUTTONS AND REINFORCED USING A SECONDARY FIXATION KIT. THE CASE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED ON 6/20/2025: ALL THE BROKEN FRAGMENTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER AR-1588BTB-2J BTB TIGHTROPE. THE CASE EXPERIENCED A DELAY OF FORTY-FIVE MINUTES, DURING WHICH ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22357028 ↗
• MalfunctionJun 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SUTURE TORE WHILE TIGHTENING. THE ENDOBUTTON COULD NOT BE USED. 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 22336548 ↗
• MalfunctionJun 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SUTURE TORE WHILE TIGHTENING. THE ENDOBUTTON COULD NOT BE USED. 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 22336441 ↗
• MalfunctionJun 4, 2025Break; Break

  ON 15TH MAY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT 1 UNIT OF AR-1588RT-2J, TIGHTROPE® II RT, WITH DEPLOYING SUTURE AND 1 UNIT OF AR-1588BTB-2J, TIGHTROPE® II BTB, WITH DEPLOYING SUTURE, BROKE INTRA OP ONE AFTER ANOTHER. THIS WAS DETECTED DURING USE IN AN ACL PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A NEW AR-1588BTB-2J. THERE IS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143693 ↗
• MalfunctionJun 4, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BTB SURGERY THE SUTURE GOT TWISTED AND STUCK IN ITSELF WHEN APPLYING TO 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 22143015 ↗
• MalfunctionMay 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY, THE DEVICE BROKE DURING TIGHTENING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 22096316 ↗
• MalfunctionMay 22, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY SOMETHING SNAPPED ONCE THE GRAFT HAD BEEN PASSED AND BUTTON FLIPPED AND SEATED AND THE TOGGLE OF THE GRAFT WAS BROUGHT FURTHER INTO THE FEMORAL SOCKET. UPON ASSESSMENT, THE BUTTON HAD SNAPPED OFF AND THE TIGHTROPE LOOP WAS JUST ONE STRAND. 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: Foreign Body In Patient

  MAUDE report 22074936 ↗
• MalfunctionMay 12, 2025Positioning Failure; Device Dislodged or Dislocated; Positioning Failure; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED ON 05/30/2025: THIS OCCURRED DURING AN ACL PROCEDURE ON (B)(6) 2025. ALL FAILED IMPLANTS WERE REMOVED FROM THE PATIENT. THERE WAS A 10-MINUTE CASE DELAY WITH NO ADDED ANESTHESIA ADMINISTERED. THERE WERE NO ADVERSE EFFECTS REPORTED ON OR AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005479 ↗
• MalfunctionMay 12, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 04/15/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1588BTB-2J TIGHTROPE II BTB ENCOUNTERED AN ISSUE DURING THE INTERNAL PASSING OF THE SUTURE DURING THE COMPLETION STEP FOR #3. THE SUTURE DID NOT WORK, BUNCHED UP, AND LOCKED UP. THE WIRE BROKE, AND THE COMPLETION SUTURE COULD NOT BE SPLICED THROUGH THE TIGHT ROPE DEVICE, MAKING IT UNUSABLE. THIS WAS DISCOVERED DURING A BTB ACL PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001539 ↗