RIGIDLOOP 232011Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886705022656), received between Jul 19, 2018 and May 8, 2026 — classified as 8 injuries, 11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Crack

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE CORTICAL FXATION FXD LOOP 20MM DEVICE SUTURE WAS FRAYING. 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 25126852 ↗
• MalfunctionFeb 4, 2026Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, WHEN USING THE CORTICAL FXATION FXD LOOP 20MM DEVICE, IT WAS OBSERVED THAT WHEN THE SUTURE WAS TIGHTENED, IT BROKE OFF. IT WAS REPORTED THAT 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 24262079 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE, WHILE USING THE CORTICAL FXATION FXD LOOP 20MM SUTURE DEVICE IT WAS OBSERVED THAT THE SUTURE WAS BROKEN OFF. IT WAS REPORTED THAT 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 24032088 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 10 FOR (B)(4). IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER DUA-SPORTS-2024-017 CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE CORTICAL FXATION FXD LOOP 20MM DEVICE FAILED AND THE PATIENT REQUIRED A RE-OPERATION OR REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22579191 ↗
• MalfunctionMar 23, 2025Crack; Crack

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE CORTICAL FXATION FXD LOOP 20MM SUTURE FRAYED WHEN TIGHTENED. 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 21673398 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP IN INDIA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE ON (B)(6) 2024 WHILE USING THE CORTICAL FIXATION FXD LOOP 20MM DEVICE AND THE MILAGRO INTSCR 9X30MM *EA ON FEMUR SIDE THE SURGERY WENT WELL AND THE PATIENT WAS DISCHARGED. AFTER TWO TO THREE MONTHS THE PATIENT SHOWED SIGN ON INFECTION AT THE OPERATED SITE AND TOOK ADVICE FROM OTHER SURGEON, WHO AFTER CHECKING THE PATIENT REPORTED AND IMPLANTS COMMENTED TO THE PATIENT ABOUT SUB STANDARD IMPLANTS USED. THE PATIENT HAS FILED COMPLIANT AGAINST OPERATIVE SURGEON DOCTOR OF NORTH STAR MULTISPECIALTY HOSPITAL KOLHAPUR. HOSPITAL HAS REQUESTED FROM COMPANY A QUALITY CERTIFICATE TO FURTHER ENDORSED CLINICALLY PROVEN IMPLANTS WERE USED IN THE SURGERY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 OF THE SAME EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20124478 ↗
• MalfunctionApr 3, 2024Crack; Crack

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY ON (B)(6) 2024, IT WAS OBSERVED THAT THE SUTURE ON THE RIGIDLOOP CORTICAL FIXATION IMPLANT 20MM DEVICE WAS FRAYED WHEN TIGHTENED. 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 19034184 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 10 OF 10 FOR (B)(4). IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER IIS (DPS_JMP_2018_067) CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RIGIDLOOP CORTICAL FIXATION IMPLANT 20MM DEVICE FAILED THAT REQUIRED A REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17309067 ↗
• MalfunctionApr 26, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A SHOULDER REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE RIGIDLOOP CORTICAL FIXATION IMPLANT 20MM DEVICE BROKE OFF WHEN TIGHTENED. CHANGED TO RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT, LONG DEVICE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. 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 16815679 ↗
• InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 10 FOR (B)(4). THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL RESEARCH REPORT FROM NEW ZEALAND FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF A RIGIDLOOP CORTICAL FIXATION IMPLANT 20MM DEVICE WHERE A PATIENT REQUIRED RE-OPERATION 195 DAYS AFTER AN INITIAL ARTHROSCOPIC KNEE PROCEDURE FOR THE REMOVAL OF IMPLANTS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15685444 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER IIS ((B)(4)) CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RIGIDLOOP CORTICAL FIXATION IMPLANT 20MM DEVICE FAILED THAT REQUIRED A REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14989567 ↗
• MalfunctionJun 7, 2022Crack; Crack

  IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURE ON THE RIGIDLOOP CORTICAL FIXATION IMPLANT 20MM DEVICE WAS FRAYED. 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 14626188 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH THAT 90 DAYS AFTER THE INITIAL FEMORAL FIXATION PROCEDURE ON AN UNKNOWN DATE USING A CORTICAL FXATION FXD LOOP 20MM DEVICE, A REVISION SURGERY WAS PERFORMED DUE TO SPORTS TRAUMA. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12913541 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL RESEARCH REPORT FROM (B)(6) FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF A CORTICAL FIXATION FXD LOOP 20MM IMPLANT DEVICE WHERE A PATIENT REQUIRED RE-OPERATION APPROXIMATELY SIX MONTHS AFTER ORIGINAL FOR REMOVAL OF THE IMPLANTS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12203308 ↗
• MalfunctionJun 28, 2019Difficult to Advance; Difficult to Advance

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A SURGERY, THE SUTURES OF THE CORTICAL FIXATION FIXED LOOP COULD NOT GET THROUGH THE FEMORAL TUNNEL. THE SURGEON CONFIRMED THAT THE HOLE FOR THE LEADING SUTURE ON THE BUTTON WAS OFF TO THE CENTER. THE SURGEON PUT THE SUTURE AGAIN AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGERY WAS DELAYED BY LESS THAN 30 MINUTES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR A CORTICAL FIXATION FXD LOOP 20MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8744284 ↗
• MalfunctionMay 6, 2019Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ACL RECONSTRUCTION, IT WAS OBSERVED THAT THE LEADING SUTURE OF THE RIGIDLOOP IMPLANT BROKE WHILE THE SURGEON ATTEMPTED TO PULL THROUGH THE ACL GRAFT TUNNELS. IT WAS REPORTED THAT THE SURGEON WAS VERY EXPERIENCED WITH PROCEDURE AND PRODUCTS. THE CASE WAS COMPLETED SUCCESSFULLY WITH A NEW RIGIDLOOP AND WORKED WITH NO CONCERNS. THERE WERE NO FRAGMENTS GENERATED FROM THE BREAKAGE. THERE WAS NO PATIENT CONSEQUENCES, BUT THERE WAS A TWO MINUTE DELAY TO USE THE NEW PRODUCT. THE IMPLANT WAS DISCARDED. IT WAS REPORTED THAT THE IMPLANT BROKE IN JUST ONE PLACE. IT WAS REPORTED THAT THE PATIENT'S BONE QUALITY WAS GOOD. IT WAS REPORTED THAT THE SURGEON/DOCTOR WAS NOT OFF AXIS. IT WAS REPORTED THAT THE SAME ONE HOLE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE IMPLANT WAS REMOVED. IT WAS REPORTED THAT THE COLOR OF THE SUTURE WAS WHITE. IT WAS REPORTED THAT THE DAMAGE/BREAKAGE OCCURRED ON MID-SUTURE. IT WAS REPORTED THAT THE SUTURE WAS IN CONTACT WITH THE INSTRUMENT DURING BREAKAGE THAT WRAPPED AROUND AN ARTERY CLIP. IT WAS REPORTED THAT A SUTURE PASSER WAS NOT USED IN THE PROCEDURE. IT WAS REPORTED THAT MITEK HIGH STRENGTH

  Patient problems: Not Applicable

  MAUDE report 8581966 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT A REPORT RECEIVED FOR IIS (INVESTIGATOR INITIATED STUDIES) WHICH IS AN ACL REGISTRY IN (B)(6) WAS UPLOADED. THE REGISTRY GOAL IS TO CAPTURE ALL ACL PROCEDURES PERFORMED IN (B)(6) AND CURRENTLY HAVE 117 PARTICIPATING SURGEONS. ALL DATA PROVIDED FROM PARTICIPATING SURGEONS IS DE-IDENTIFIED AND CAPTURES ALL PROCEDURES/DEVICES ACROSS ALL INDUSTRY MANUFACTURERS. ON OPENING THE REPORT TO REVIEW THE INFORMATION, AFFILIATE IDENTIFIED THE IMPLANT COMPLICATION RATES FOR ALL DEPUY PRODUCTS CURRENTLY CAPTURED IN THE REGISTRY ON THE LAST PAGE OF THE REPORT. ON DISCUSSION WITH MEDICAL DIRECTOR, THE INFORMATION IS BEING PROVIDED BY THE AFFILIATE TO THE PRODUCT SAFETY FOR ENTRY INTO THE COMPLAINTS SYSTEM AS ¿INFORMATION ONLY¿ GIVEN THE DATA IS CUMULATIVE OVER THE DURATION OF THE REGISTRY; NO FURTHER INFORMATION IS AVAILABLE. THERE IS THE POTENTIAL OF DUPLICATIVE REPORTING IF ANY OF THESE CASES HAVE ALREADY BEEN INDIVIDUALLY (REPORTED TO THE COMPANY) AT THE POINT OF OCCURRENCE (FROM EITHER SURGEON/EMPLOYEE CLINICAL SPECIALIST) AS STATED BY THE AFFILIATE. THE REPORT STATES THAT 6 CORTICAL FXATION FXD LOOP 20 MM; PRODUCT CODE 232011, FAILED DUE TO UNKNO

  Patient problems: No Code Available

  MAUDE report 8375808 ↗
• MalfunctionAug 22, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING GRACILIS FEMITENDINOSIS TRANSPLANT, THE SUTURE AND POLYETHYLENE LOOP HAD SEPARATED. ACCORDING TO THE REPORT, THE SURGEON PASSED THE GRAFT THROUGH THE LOOP UNTIL THE LOOP WAS AT THE MID-POINT OF THE GRAFT. WITH A SURGICAL MARKER, HE MADE A MARK ON THE GRAFT FOR THE FEMORAL SOCKET DRILL DEPTH. USING A PASSING SUTURE, HE PULLED THE LEADING (WHITE) AND TRAILING (GREEN) SUTURES THROUGH THE TIBIAL AND FEMORAL TUNNELS. THEN HE USED THE WHITE LEADING SUTURE TO PULL THE IMPLANT/GRAFT THROUGH THE FEMORAL TUNNEL UNTIL THE MARK ON THE GRAFT WAS VISIBLE AT THE APERTURE. IN THIS PART THE LOOP BROKE AND DOCTOR TOOK S&N ENDOBUTTON IMPLANT. THE PROCEDURE WAS COMPLETED USING S&N ENDOBUTTON. IT WAS REPORTED THAT THE ISSUE DID NOT EXTEND THE PROCEDURE LONGER THAN 30 MINUTES. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7804636 ↗
• MalfunctionJul 19, 2018Break; Break

  IT WAS REPORTED BY THE HOSPITAL THAT THE EVENT OCCURRED DURING AN ACL RECONSTRUCTION UTILIZING AM PORTAL, HAMSTRING AUTOGRAFT, RIGIDLOOP, BIOINTRAFIX. 8.5 MM TUNNELS WERE REAMED MATCHING THE SIZE OF THE GRAFT, ACCORDING TO THE REPORT, THE SURGEON FOLLOWED PROTOCOL BY REAMING 10MM GREATER THAN DESIRED GRAFT IN THE FEMORAL TUNNEL TO ENABLE THE RIGIDLOOP DEVICE TO FLIP ON THE CORTEX. A PASSING SUTURE WAS UTILIZED TO INTRODUCE THE GRAFT INTO THE JOINT. THE LEAD (WHITE) ¿UTILITY¿ SUTURE WAS WRAPPED AROUND A COAKER IN ORDER TO FACILITATE PASSING THE GRAFT. IT WAS REPORTED THAT THE SURGEON HAD DIFFICULTY IN GETTING THE BUTTON/GRAFT CONSTRUCT THROUGH THE FEMORAL TUNNEL AND EVENTUALLY BROKE THE LEAD SUTURE DURING HIS ATTEMPT. SUTURE APPEARED TO BREAK AT THE BUTTON EYELET AS BOTH STRANDS OF THE BROKEN UTILITY SUTURE WERE IDENTICAL IN LENGTH. GRAFT WAS RETURNED TO THE BACK TABLE AND A # 5 FIBERWIRE SUTURE WAS THREADED INTO THE EYELET TO SERVE AS THE LEAD SUTURE ON THE SECOND, SUCCESSFUL ATTEMPT. IT WAS REPORTED THAT THE POSSIBLE CAUSE OF DIFFICULTY IN PASSING THE GRAFT WAS BONE DEBRIS IN THE TUNNEL FROM REAMING MAY NOT HAVE BEEN COMPLETELY REMOVED FROM THE TUNNEL PRIOR TO INTRODUCTION OF THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7702935 ↗