Arthrex® AR-1288RTIB-FC3Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867379978), received between Nov 7, 2023 and Oct 27, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Break; Break

  ON 10/14/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE FLIPCUTTER III FROM AN (B)(6) TIGHTROPE II RT WITH FIBERTAPE IB, FLIPCUTTER III, AND FIBERSTICK IMPLANT SYSTEM BROKE AND WAS UNABLE TO BE USED. THIS WAS DISCOVERED DURING A PROCEDURE ON AR-1288RTIB-FC3 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 10/20/2025: DURING THE PROCEDURE, THE FLIPCUTTER BROKE WHILE RETRO DRILLING INSIDE THE PATIENT. FORTUNATELY, ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED WITHOUT COMPLICATION. TO COMPLETE THE CASE, AN INDIVIDUAL AR-1240FF FLIPCUTTER III WAS USED. THE INCIDENT DID NOT RESULT IN ANY SURGICAL DELAY, AND NO ADDITIONAL ANESTHESIA WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 23393366 ↗
• MalfunctionSep 19, 2025Break; Break

  ON 08/29/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE BLACK GEAR HOUSING OF A FLIPCUTTER III, PART OF THE AR-1288RTIB-FC3 TIGHTROPE II RT-IB IMPLANT SYSTEM, BROKE DURING BACK-REAMING. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 09/08/2025: DURING AN ACL RECONSTRUCTION PROCEDURE ON 08/29/2025, THE BLACK BULBOUS COMPONENT OF A FLIPCUTTER III, PART OF THE AR-1288RTIB-FC3 TIGHTROPE II RT-IB IMPLANT SYSTEM, SPLIT IN HALF. THIS DID NOT OCCUR OVER AN OPEN INCISION, AND NO FRAGMENTS WERE REPORTED TO HAVE ENTERED THE PATIENT. THE BROKEN PIECE WAS REMOVED FROM THE SURGICAL FIELD. THE CASE WAS COMPLETED USING A NEW AR-1204FF FLIPCUTTER III DRILL. THERE WAS A BRIEF CASE DELAY OF APPROXIMATELY TWO MINUTES, AND IT IS UNCLEAR WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096800 ↗
• MalfunctionJan 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-1288RTIB-FC3 FLIPCUTTER DRILL SEPERATED, SURGEON USED ANOTHER DRILL TO COMPLETE PROCEDURE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477304 ↗
• MalfunctionJan 8, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 12/11/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1288RTIB-FC3 IMPLANT SYSTEM TIGHTROPE® II RT HAD SOME KIND OF TWIST IN THE WHITE SUTURE THAT COULD NOT ALLOW THE SUTURE TO PASS THROUGH THE BUTTON TO BRING THE GRAFT INTO THE SOCKET. THIS OCCURRED DURING AN ACL LIGAMENT RECONSTRUCTION ON (B)(6) 2023 WHERE THE CASE WAS COMPLETED BY REMOVING THE DEVICE AND PLACING THE GRAFT ON ANOTHER TIGHTROPE.

  Patient problems: Insufficient Information

  MAUDE report 18464212 ↗
• MalfunctionNov 7, 2023Defective Device; Defective Device

  ON (B)(6) 2023 IT WAS REPORTED BY A SALES REP, VIA PHONE, THAT DURING AN ACL RECONSTRUCTION PROCEDURE, THE BLADE ON THE FLIPCUTTER 3 (THAT IS A COMPONENT OF THE AR-1288RTIB-FC3. RT IB TIGHTROPE W FLIPCUTTER III DRILL), DID NOT DEPLOY. THE REP WAS ABLE TO QUICKLY REPLACE THE FLIPCUTTER WITH ANOTHER AND THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT.

  Patient problems: Insufficient Information

  MAUDE report 18086922 ↗