RIGIDLOOP 232449Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705024117), received between Sep 12, 2018 and Aug 20, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE RGDLOOP ADJUSTABLE XLARG DEVICE WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 22850522 ↗
• MalfunctionDec 13, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING A ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE ON (B)(6) 2023 THE RGDLOOP ADJUSTABLE DEVICE TENSION SUTURE BROKE AFTER THE GRAFT WAS IN PLACE AND THE SURGEON STARTED TO TENSION THE GRAFT. THE SURGEON TOOK THE GRAFT OUT, REDID WITH SPEED TRAP TWO TIMES AND TWO FURTHER SETS WERE USED WHEN THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18321096 ↗
• MalfunctionJan 25, 2019Fracture; Fracture

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT THE LEAD THREAD ON THE RGDLOOP ADJUSTABLE XLARG DEVICE BROKE WHEN THE SURGEON ATTEMPTED TO INSERT IT INTO THE INTRA-ARTICULAR BONE HOLE DURING AN ANTERIOR CRUCIATE LIGAMENT ACL RECONSTRUCTION SURGERY. ACCORDING TO THE REPORTER, THE SURGEON SUSPECTED THAT THE LEAD THREAD HIT THE BONE HOLE FIRMLY AT THE EDGE OF THE HOLE. IT WAS REPORTED THAT THE DEVICE WAS BRAND NEW AND ITS FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 8278182 ↗
• MalfunctionOct 29, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT THE SUTURE OF THE FIRST RIGIDLOOP ADJUSTABLE IMPLANT SNAPPED OFF COMPLETELY WHEN THE SURGEON PULLED TOO HARD ON THE LEADING SUTURE. A SMALLER RIGIDLOOP AND ADJUSTABLE STANDARD WAS USED TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE PROCEDURE. 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 8016840 ↗
• MalfunctionSep 12, 2018Break; Break

  IT WAS REPORTED DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION, WHILE TIGHTENING THE GRAFT, THE LOOP SUTURE SNAPPED ON THE GRAFT SIDE OF THE BUTTON. THIS HAS CAUSED THE RIGIDLOOP ADJUSTABLE BUTTON TO BE UNUSABLE. IN TURN, THIS HAS INCREASED THE SURGICAL TIME BY APPROXIMATELY TWENTY (20) MINUTES, AND THE ACL REPAIR IS NOT OF THE STANDARD REQUIRED. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED VIA E-MAIL FROM THE AFFILIATE ON OCTOBER 13, 2015: IT WAS NOTED THE SURGEON WAS USING THE IMPLANT "OFF-LABEL". HE WAS USING THE IMPLANT ON THE TIBIA, AND NOT THE FEMUR AS INDICATED. HE HAS ADVISED ME THAT DUE TO HIS GRAFT PREP TECHNIQUE, HE HAD ADDITIONAL SUTURES FROM THE GRAFT THAT HE THREADED THROUGH THE RIGID LOOP ADJUSTABLE BAR AND TIED OFF TO COMPLETE THE PROCEDURE. IT WAS NOTED IT IS HIGHLY LIKELY THAT THE SURGEON ASSISTANT DAMAGED THE LOOP SUTURE DURING THE GRAFT PREP LEADING TO THE BREAKAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7870440 ↗