RIGIDLOOP 232014Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886705022663), received between Aug 6, 2018 and Jun 2, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16, 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.

• 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 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25366505 ↗
• MalfunctionDec 11, 2025Break; Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE, WHEN USING THE CORTICAL FXATION FXD LOOP 25MM SUTURE DEVICE, IT WAS OBSERVED THAT THE SUTURE BROKE OFF WHEN IT WAS TIGHTENED. 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 23778405 ↗
• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE CORTICAL FIXATION FXD LOOP 25MM DEVICE, WHEN TIGHTENING THE SUTURE, THE SUTURE WAS BROKEN OFF. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467408 ↗
• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE CORTICAL FXATION FXD LOOP 25MM DEVICE, WHEN TIGHTENING THE SUTURE, THE SUTURE WAS BROKEN OFF. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467381 ↗
• MalfunctionJan 24, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON (B)(6)2024 THE CORTICAL FIXATION FXD LOOP 25MM DEVICE WHEN TIGHTENED THE SUTURE, THE SUTURE WAS BROKEN 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 18570698 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 7 OF 10 FOR PC-001386481.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 25MM 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 17309057 ↗
• 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 25MM 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 14990058 ↗
• 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 (B)(4) 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 FIXATION FXD LOOP 25MM; (B)(4), FAILED DUE TO UNKNOWN REASONS

  Patient problems: No Code Available

  MAUDE report 8376069 ↗
• MalfunctionAug 6, 2018Break; Break

  IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE TENSION WAS APPLIED IN THE BONE HOLE DURING ACL RECONSTRUCTION SURGERY ON (B)(6) 2018. THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEM ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. IT WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS LESS THAN 30-MINS. SURGICAL DELAY AND NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7752116 ↗