RIGIDLOOP 232448Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 10886705024100), received between May 29, 2018 and Sep 2, 2026 — classified as 5 injuries, 91 malfunctions.

The most frequently reported specific device problem is “Break” (83 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 96 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Break

  It was reported that during an Anterior Cruciate Ligament Reconstruction surgery, it was discovered that the loop of the RGDLOOP ADJUSTABLE LONG device snapped while pulling up the graft. There were no delays to the surgical procedure. It was not reported if a spare device was available for use. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50563202 ↗
• MalfunctionJun 15, 2026Break

  IT WAS REPORTED THAT DURING A RIGHT ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION SURGICAL PROCEDURE IT WAS OBSERVED THAT THE INTRAFX ADVBR SCW10X23W/LGSHTH DEVICE BROKE. IT WAS REPORTED THAT THE DEVICE WAS REMOVED AND REPLACED INTRA-OP. NO ADDITIONAL IMPACT TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25510778 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). POST MARKET COMPLICATION RECEIVED FOR RE-TEARS OR NEW TEARS (LEFT KNEE DISPLACED BUCKET HANDLE MEDIAL MENISCUS TEAR). DATE OF EVENT: (B)(6) 2025. DATE OF IMPLANT: (B)(6) 2023 (LEFT ACL TEAR, MEDIAL MENISCUS TEAR, LATERAL MENISCUS TEAR). DATE OF REOPERATION/REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: RE-OPERATION WITH NO IMPLANT REMOVED/IMPLANTED. DEPUY SYNTHES PRODUCTS USED: RGDLOOP ADJUSTABLE LONG. CATALOG NUMBER: 232448. LOT NUMBER: 8L67308. DEPUY SYNTHES PRODUCTS USED: TRUESPAN 12 DEGREE PEEK. CATALOG NUMBER: 228151. LOT NUMBER: 9L71051. DEPUY SYNTHES PRODUCTS USED: INTRAFIX ADVANCE 10X23 SCREW & LARGE 23MM SHEATH. CATALOG NUMBER: 254803. LOT NUMBER: 9L62950. DEPUY SYNTHES PRODUCTS USED: 5.5MM HEALIX ADVANCE SP BIOCOMPOSITE ANCHOR. CATALOG NUMBER:222424. LOT NUMBER: 116L683. . REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25301074 ↗
• MalfunctionMar 25, 2026Break

  IT WAS REPORTED THAT DURING ANTERIOR CRUCIATE LIGAMENT SURGERY, WHEN THE RIGIDLOOP SUTURE WAS TIGHTENED, THE SUTURE WAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689692 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE THAT THE RGDLOOP ADJUSTABLE LONG DEVICE SUTURE BROKE OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676782 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THAT THE RGDLOOP ADJUSTABLE LONG DEVICE WHEN TIGHTENED THE SUTURE, THE SUTURE WAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24676573 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE UNSPECIFIED SURGICAL PROCEDURE THE TWO (X2) RGDLOOP ADJUSTABLE LONG DEVICES, TWICE IN A ROW, THE SUTURE THEIR POLE SUTURE TO PULL THE GRAFT INTO THE FEMORAL TUNNEL SNAPPED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2026. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24249222 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE UNSPECIFIED SURGICAL PROCEDURE THE TWO (X2) RGDLOOP ADJUSTABLE LONG DEVICES, TWICE IN A ROW, THE SUTURE THEIR POLE SUTURE TO PULL THE GRAFT INTO THE FEMORAL TUNNEL SNAPPED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2026. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24249203 ↗
• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE RGDLOOP ADJUSTABLE LONG DEVICE ADJUSTABLE IMPLANT WAS DAMAGED. INITIALLY THE GRAFT WAS LOADED AND THE BUTTON WAS FLIPPED, AT THE TIME OF SHORTENING THE GRAFT THE LOOP THREADS WERE BROKEN THEN THE IMPLANT WAS TAKEN OUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A FIFTEEN TO TWENTY MINUTE DELAY IN THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435989 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE RGDLOOP ADJUSTABLE LONG DEVICE IMPLANT WAS DAMAGED. INITIALLY GRAFT WAS LOADED, AND THE BUTTON WAS FLIPPED. AT THE TIME OF PULLING THE GRAFT VIA LEADING SUTURE THE LOOP THREADS WERE BROKEN THEN IMPLANT WAS TAKEN OUT. THE SURGEON KEPT ASIDE THE DAMAGED IMPLANT AND OPENED A NEW ONE, IN ALL TWO IMPLANTS WERE USED WHICH FUNCTIONED PROPERLY, ALLOWING THE SURGERY TO BE COMPLETED SUCCESSFULLY. THERE WAS A FIFTEEN TO TWENTY MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310782 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE RGDLOOP ADJUSTABLE LONG DEVICE SUTURE WAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22717151 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN THE SURGEON TIGHTENED THE RGDLOOP ADJUSTABLE LONG SUTURE DEVICE, THE SUTURE WAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716734 ↗
• MalfunctionJul 18, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT WHEN THE LIGAMENT WAS RAISED WITH THE WHITE THREAD OF THE RGDLOOP ADJUSTABLE LONG ANCHOR DEVICE, THE LATTER BURSTS AND ANOTHER IMPLANT WAS REQUIRED TO CONTINUE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22540806 ↗
• MalfunctionJun 24, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE WHILE USING THE RGDLOOP ADJUSTABLE LONG DEVICE FLIPPING SUTURE FOR THE BUTTON FLIPPING BROKE WHILE BEING PULLED. SUBSEQUENTLY, THE LEADING SUTURE ALSO BROKE WHILE PULLING. THE SURGEON KEPT ASIDE THE DAMAGED IMPLANT AND OPENED A NEW ONE, WHICH FUNCTIONED PROPERLY, ALLOWING THE SURGERY TO BE COMPLETED SUCCESSFULLY. THERE WAS A DELAY OF FIVE TO TEN MINUTES IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322229 ↗
• MalfunctionFeb 7, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE 4RGDLOOP ADJUSTABLE LONG DEVICE HAD A FAULT WITH THE INPUT DETECTED. THE FAULT WAS DUE TO A FACTORY ERROR AND THEREFORE THE PROCEDURE COULD NOT BE PERFORMED WITH THAT INPUT. IT WAS UNKNOWN IF A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS UNKNOWN IF THERE WAS A DELAY IN THE PROCEDURE REPORTED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337649 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 4 FOR (B)(4). IT WAS REPORTED THROUGH A POST MARKET CLINICAL RESEARCH STUDY THAT A PATIENT HAD UNDERGONE AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION WITH MENISCAL REPAIR PROCEDURE ON (B)(6) 2024, USING A MILAGRO ADVANCE SCREW 10X23MM DEVICE, A RGDLOOP ADJUSTABLE LONG, A TRUESPAN 12 DEGREE PEEK DEVICE AND A 4.75 HEALIX ADVANCE KNTLS PEEK DEVICE. ACCORDING TO THE REPORT, THE PATIENT HAD A RETEAR OF HIS RECONSTRUCTED ACL RESULTING IN RE-OPERATION/REVISION WHERE ALL OF THE INITIAL HARDWARE WAS REMOVED AND REVISED. THERE WERE NO REPORTS OF DELAY IN THE PROCEDURE REPORTED. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20835317 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE WHITE THREAD OF THE RGDLOOP ADJUSTABLE LONG DEVICE BURST. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20818482 ↗
• MalfunctionJul 2, 2024Break; Material Deformation; Break; Material Deformation

  THIS IS REPORT 3 OF 5 FOR (B)(4). IT WAS REPORTED THROUGH CLINICAL RESEARCH THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE RGDLOOP ADJUSTABLE LONG DEVICE WAS DEFORMED, WARPED AND DISTORTED THAT LED TO DEVICE BREAKAGE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19657490 ↗
• MalfunctionJun 5, 2024Break; Break

  IT WAS REPORTED FROM COLOMBIA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE RGDLOOP ADJUSTABLE LONG DEVICE BURST AT THE TIME OF PERFORMING THE TENSION OF THE GRAFT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19470322 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE THE RGDLOOP ADJUSTABLE LONG DEVICE, AT THE TIME OF UPLOADING THE GRAFT, WITHOUT HAVING FINISHED PASSING THROUGH THE TIBIAL TUNNEL, THE WHITE STRAND THAT CONTAINED THE GRAFT BURSTS, WHICH IS WHY ANOTHER IMPLANT IS REQUIRED TO BE PASSED. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458560 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE THE RGDLOOP ADJUSTABLE LONG DEVICE, WHEN TENSIONING THE GRAFT, THE SUTURE CONTAINING THE GRAFT BURSTS. THERE IS NO PATIENT INVOLVEMENT AND IT IS RESOLVED BY PASSING ANOTHER REFERENCE THAT IS IN THE ROOM. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458075 ↗
• MalfunctionMar 25, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING AN ACROMIOCLAVICULAR JOINT SURGICAL PROCEDURE, IT WAS FOUND THAT WHILE USING THE RGDLOOP ADJUSTABLE LONG DEVICE SUTURE BREAKAGE. IT WAS REPORTED THAT DURING THE PROCEDURE THAT WHEN TIGHTENING THE SUTURE, THE SUTURE WAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969620 ↗
• MalfunctionMar 12, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN COLOMBIA THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RGDLOOP ADJUSTABLE LONG DEVICE BURST WHEN POSITIONING THE GRAFT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE PROCEDURE OR WHETHER A LIKE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885858 ↗
• MalfunctionMar 7, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE RGDLOOP ADJUSTABLE LONG DEVICE SUTURE COULD NOT TIGHTENED. DURING AN IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD FOREIGN SUBSTANCE/DEBRIS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857476 ↗
• MalfunctionMar 6, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE PERFORMED ON (B)(6) 2024 IT WAS OBSERVED THAT WHEN THE RGDLOOP ADJUSTABLE LONG SUTURE DEVICE WAS TIGHTENED, THE SUTURE WAS BROKEN OFF. IT WAS REPORTED THAT ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852004 ↗