RIGIDLOOP 232009Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886705022649), received between Feb 27, 2019 and Jun 2, 2026 — classified as 8 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE THE CORTICAL FXATION FXD LOOP 15MM DEVICE BROKE. THE LENGTH OF THE GRAFT INSERTION WAS ADJUSTED, AND A 25MM UNIT WAS OPENED AND USED, BUT THE LEADING THREAD BROKE AGAIN. 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. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25366501 ↗
• MalfunctionMay 28, 2026Crack

  THIS IS REPORT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY, THE INTRAFIX DEVICE SCREW WAS BROKEN WHEN INSERTED. ALL BROKEN PARTS WERE REMOVED FROM THE PATIENT. CHANGED TO ANOTHER SAME PRODUCT TO CONTINUE THE SURGERY. IT WAS NOTED THAT THE RIGIDLOOP DEVICE 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 25317547 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 3 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 15MM 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 22579188 ↗
• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, THE CORTICAL FXATION FXD LOOP 15MM DEVICE, 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 22104022 ↗
• InjuryApr 10, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ACROMIOCLAVICULAR JOINT DISLOCATION. IN (B)(6)2024, IT WAS FOUND THE CORTICAL FXATION FXD LOOP 15MM SUTURE BROKE. IT WAS REPORTED THAT A SECONDARY PROCEDURE WAS PERFORMED TO CHANGE TO ANOTHER DEVICE. THE PATIENT WAS RECOVERING NOW. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19077387 ↗
• MalfunctionMar 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE, IT WAS OBSERVED THAT WHEN THE SUTURE WAS TIGHTENED ON THE CORTICAL FXATION FXD LOOP 15MM DEVICE, THE SUTURE WAS DETACHED FROM THE ANCHOR. 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 18855323 ↗
• MalfunctionJan 18, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE CORTICAL FIXATION FXD LOOP 15MM DEVICE WHEN TIGHTENING THE SUTURE, THE SUTURE BROKE OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 18536901 ↗
• MalfunctionDec 6, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE ON (B)(6) 2023 THE CORTICAL FXATION FXD LOOP 15MM DEVICE OPENED THE OUTER BOX (OUTER BOX WAS GOOD) AND NOTED POOR SEALING OF THE INNER PACKAGING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 18273986 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 8 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 15MM 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 17309061 ↗
• MalfunctionJan 9, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN BRAZIL THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE GREEN WIRE ON THE RIGIDLOOP CORTICAL FIXATION IMPLANT 15MM DEVICE BROKE. 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 16126723 ↗
• 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 15MM 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 14989792 ↗
• MalfunctionJul 12, 2022Break; Break

  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 DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RIGIDLOOP CORTICAL FIXATION IMPLANT 15MM DEVICE BROKE. 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 14989614 ↗
• 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 15MM DEVICE, A REVISION SURGERY WAS PERFORMED DUE TO TRAUMA. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12913713 ↗
• 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 95 DAYS AFTER THE INITIAL FEMORAL FIXATION PROCEDURE ON AN UNKNOWN DATE USING A CORTICAL FXATION FXD LOOP 15MM 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 12910797 ↗
• 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 CORTICAL FXATION FXD LOOP 15MM 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 12203147 ↗
• MalfunctionNov 15, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING AND ACL CASE THE PINS OF THE ABSOLUTE G-W NTNL 1.1MMX15 6PK BROKE, THE BROKEN TIP WAS TRAPPED IN THE GRAFT AND THE SURGEON HAD TO REMOVE THE MILAGRO ADVANCE SCREW 11X30MM AND THE CORTICAL FXATION FXD LOOP 15MM FROM FEMORAL SIDE IN ORDER TO TAKE THE GRAFT OUT AND LOOKED FOR THE WIRE TIP, THE GUIDE WIRE TIP WAS FOUND AND WAS REMOVED FROM THE PATIENT, BUT THE SCREW WAS A LITTLE DEFORMED. THE PROCEDURE WAS COMPLETED USING DIFFERENT DEVICES. NO PATIENT CONSEQUENCE WAS REPORTED. HOWEVER, THERE WAS A SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTED A 30 MINUTE SURGICAL DELAY. THE AFFILIATE ALSO REPORTED ONLY ONE FRAGMENT WAS GENERATED AND IT WAS SUCCESSFULLY REMOVED BY THE SURGEON. IT WAS ALSO REPORTED THE BROKEN TIP WAS TRAPPED IN THE GRAFT AND SURGEONS NEED TO REMOVE THE 231824 AND 15MM RIGIDLOOP 232009 X1 (LOT 4L23984) AT FEMORAL SIDE IN ORDER TO TAKE THE GRAFT OUT AND SEARCH FOR THE GUIDE WIRE TIP. THE AFFILIATE REPORTED THAT NORMAL FORCE WAS APPLIED TO REMOVE THE SCREW.

  Patient problems: Not Applicable

  MAUDE report 9330950 ↗
• MalfunctionFeb 27, 2019Break; Break

  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 1 CORTICAL FXATION FXD LOOP 15MM PRODUCT CODE 232009, BROKE INTRA-OP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8375980 ↗
• 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 13 CORTICAL FIXATION FXD LOOP 15MM; PRODUCT CODE: 232009, FAILED DUE TO UNK

  Patient problems: No Code Available

  MAUDE report 8375612 ↗