Arthrex® AR-1288BTBIB-FC3Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867379961), received between Dec 7, 2021 and Sep 30, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Twisted/Bent

  On 11-Sep-2026, a sales representative reported via SEMS-07494925 that an AR-1288BTBIB-FC3 TightRope II BTB-IB Implant System had an issue in which the FlipCutter III tip became bent and could not be fully closed for removal from the drill sleeve. This occurred while creating the femoral PCL tunnel. The FlipCutter and drill sleeve were removed together, and the tunnel was found to be adequate for passing a suture, allowing the procedure to continue without complications. After the procedure, the device had to be cut with a pin cutter to remove the drill sleeve. This issue was discovered during a PCL reconstruction procedure on 11-Sep-2026. No harm to the patient was reported.Additional information was received on 17-Sep-2026:The bent tip was first identified upon completion of drilling the femoral PCL socket. The FlipCutter was presumed to have become bent while deployed and retro-cutting, and the issue was identified when attempting to close the FlipCutter.The reporter stated that unusually hard bone was encountered during the procedure. As a result, the FlipCutter did not appear to cut as efficiently as expected, and additional in-line pressure was reportedly applied to facilitat

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947007 ↗
• MalfunctionMay 19, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1288BTB-IB- FC3 INTERNAL BRACE FLIPCUTTER BLADE BROKE DURING INITIAL DRILLING. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE COMPLETED USING ANOTHER FLIPCUTTER. ALL FRAGMENTS REMOVED. NO DELAY TO CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044431 ↗
• MalfunctionAug 26, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 07/15/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE TIGHTROPE SUTURE FROM AN AR-1288BTBIB-FC3 BTB IB TIGHTROPE WITH FLIPCUTTER III DRILL WAS KNOTTED. THE SUTURES THAT WRAP AROUND THE NUMBER TWO SECTION OF THE CARD WERE JUMBLED IN A KNOT AND IT WAS NOT NOTICED UNTIL AFTER THE CONVERSION WAS MADE FOR THE TIGHTROPE. THE KNOT IN THE SUTURE PREVENTED TENSIONING OF THE IMPLANT. EVERYTHING WAS CUT OUT, AND A SECOND AR-1288BTBIB-FC3 BTB IB TIGHTROPE WITH FLIPCUTTER III DRILL KIT WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN ACL BONE TENDON BONE RECONSTRUCTION PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 20065379 ↗
• MalfunctionJun 20, 2024Component Missing; Component Missing

  ON 3/15/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1288BTBIB-FC3 BTB IB TIGHTROPE WITH A FLIPCUTTER III DRILL WAS MISSING THE AR-1588BTB-IB INTERNALBRACE FROM THE KIT. INSTEAD, IT CONTAINED AN AR-1288RTT-FC3FIBERTAG TIGHTROPE WITH FLIPCUTTER III, LOT NUMBER 14688120. THIS WAS DISCOVERED UPON OPENING THE PACKAGE DURING AN ACLR PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED WITH ANOTHER AR-1288BTBIB-FC3 BTB IB TIGHTROPE WITH A FLIPCUTTER III DRILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575547 ↗
• InjuryDec 1, 2023Break; Break

  ON 11/2/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1288BTBIB-FC3 TIGHTROPE II BTB-IB IMPLANT SYSTEM WITH FLIPCUTTER III AND FIBERSTICK HAD AN ISSUE. THE BLADE BROKE OFF WHEN RETRODRILLING IN THE TUNNEL ON THE FEMUR. THE CASE WAS COMPLETED USING ANOTHER PRODUCT WITH A DIFFERENT TECHNIQUE TO DRILL THE TUNNEL THAT THE SURGEON WAS UNFAMILIAR WITH, WHICH CAUSED A CASE DELAY OF AN HOUR AND THIRTY MINUTES WITH THE ADDITIONAL THIRTY-MINUTE DELAY TO RETRIEVE THE FRAGMENTS WITH NO FRAGMENTS LEFT INSIDE THE PATIENT. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE ON 11/2/2023. ADDITIONAL INFORMATION RECEIVED ON 11/4/2023: THE CASE WAS COMPLETED USING AN AR-1400F-105 FLEXIBLE REAMER WITH A FLEXIBLE GUIDE PIN 10.5MM AND USING A DIFFERENT TECHNIQUE TO DRILL THE TUNNEL, "FLEXIBLE REAMER, MEDIAL PORTAL DRILLING," THAT THE SURGEON WAS UNFAMILIAR WITH, WHICH CAUSED A CASE DELAY OF AN HOUR AND THIRTY MINUTES WITH THE ADDITIONAL THIRTY-MINUTE DELAY TO RETRIEVE THE FRAGMENTS WITH NO FRAGMENTS LEFT INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18247768 ↗
• MalfunctionApr 18, 2022Break

  ON 03/28/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA PHONE THAT A AR-1288BTBIB-FC3 FLIPCUTTER BROKE. THIS OCCURRED ON (B)(6) 2022 DURING A PCL RECONSTRUCTION WHEN THEY WERE DRILLING THE CUTTING PIECE CAME OFF, THE FRAGMENTS WERE RETRIEVED. THE CASE WAS COMPLETED OPENING ANOTHER FLIPCUTTER, AND THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14135307 ↗
• MalfunctionDec 7, 2021Break

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA THE PHONE THAT THE BLADE OF AN AR-1204FF FLIPCUTTER, FROM THE AR-1288BTBIB-FC3 TIGHTROPE KIT, BROKE OFF INTO 2 PIECES AS THE SURGEON WAS DRILLING. ALL FRAGMENTS WERE REMOVED USING A GRASPER. THIS WAS DISCOVERED DURING USE IN AN ACL PROCEDURE. THE CASE WAS COMPLETED BY OPENING A SINGLE AR-1204FF.

  Patient problems: Insufficient Information

  MAUDE report 12953884 ↗
• MalfunctionDec 7, 2021Material Separation

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA THE PHONE THAT THE BLADE OF AN AR-1204FF FLIPCUTTER, FROM THE AR-1288BTBIB-FC3 TIGHTROPE KIT, BROKE OFF INTO 2 PIECES AS THE SURGEON WAS DRILLING. ALL FRAGMENTS WERE REMOVED USING A GRASPER. THIS WAS DISCOVERED DURING USE IN AN ACL PROCEDURE. THE CASE WAS COMPLETED BY OPENING A SINGLE AR-1204FF.

  Patient problems: Foreign Body In Patient

  MAUDE report 12953879 ↗
• MalfunctionDec 7, 2021Break

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA THE PHONE THAT THE BLADE OF AN AR-1204FF FLIPCUTTER, FROM THE AR-1288BTBIB-FC3 TIGHTROPE KIT, BROKE OFF INTO THE BONE AS THE SURGEON WAS DRILLING. ALL FRAGMENTS WERE REMOVED USING A GRASPER. THE CASE WAS COMPLETED BY OPENING A SINGLE AR-1204FF.

  Patient problems: Insufficient Information

  MAUDE report 12953853 ↗