RIGIDLOOP 232025Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705022748), received between Feb 22, 2023 and Dec 16, 2025 — classified as 8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE RIGIDLOOP PASSING PIN 2.4MM DEVICE, THE END OF THE PASSING PIN BROKE OFF AND WAS STUCK IN THE FEMORAL TUNNEL. THE SURGEON DECIDED TO LEAVE IT IN THE BONE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REAL DELAY IN THE PROCEDURE BUT THERE WAS ADDED XRAY TIME. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23817025 ↗
• MalfunctionJul 18, 2025Break; Break

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE RIGIDLOOP DISPOSABLES SYSTM DEVICE CREATED METAL SHAVINGS WHEN DRILLING THROUGH THE 6.5MM FEMORAL AIMER ON TRAY WHILE IN USE WITH THE RIGIDLOOP PASSING PIN 2.4MM DEVICE. THERE WERE NO REPORTS OF DELAYS TO THE PROCEDURE REPORTED. 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 22542842 ↗
• MalfunctionJun 9, 2025Break; Break

  REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, IT WAS OBSERVED THAT THE RIGIDLOOP PASSING PIN 2.4MM DEVICE PRODUCED A LOT OF METAL DEBRIS WHEN IT WAS DRILLING THROUGH THE FEMORAL OFFSET AIMER ANTEROMEDIAL FEMORAL AIMER 7.5MM -NS DEVICE. ANOTHER RIGIDLOOP PASSING PIN 2.4MM DEVICE WAS USED BUT THE SAME ISSUE OCCURRED. 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 22165588 ↗
• MalfunctionJun 9, 2025Break; Break

  REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, IT WAS OBSERVED THAT THE RIGIDLOOP PASSING PIN 2.4MM DEVICE PRODUCED A LOT OF METAL DEBRIS WHEN IT WAS DRILLING THROUGH THE FEMORAL OFFSET AIMER ANTEROMEDIAL FEMORAL AIMER 7.5MM -NS DEVICE. ANOTHER RIGIDLOOP PASSING PIN 2.4MM DEVICE WAS USED BUT THE SAME ISSUE OCCURRED. 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 22165587 ↗
• MalfunctionAug 9, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, A RIGIDLOOP PASSING PIN 2.4MM DEVICE WAS USED. ACCORDING TO THE REPORT, THE GUIDE WAS BENT. IT WAS FURTHER REPORTED THAT THE RILL BIT THAT PASSED OVER IT ADJUSTED A LOT. IT WAS FURTHER REPORTED THAT WHEN TRYING TO PASS THE BIT CANNULATED ON THE GUIDE PIN, IT PRESENTED A LITTLE RESISTANCE, HAVING TO MAKE A GREATER FORCE. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. 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 17490947 ↗
• MalfunctionAug 1, 2023Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  THIS IS REPORT 3 OF 3 FOR (B)(4) . IT WAS REPORTED BY THE AFFILIATE IN BELGIUM THAT THE RIGIDLOOP PASSING PIN 2.4MM DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE PIN WAS FOUND BROKEN; AND THE BROKEN PIECE WERE NOT RETURNED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17436687 ↗
• MalfunctionJun 19, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN HONG KONG THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE RIGIDLOOP PASSING PIN 2.4MM DEVICE BROKE INTO TWO PARTS WHEN THE SURGEON WAS REAMING IT THROUGH THE FEMUR. 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 17153432 ↗
• MalfunctionFeb 22, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE RIGIDLOOP PASSING PIN 2.4MM DEVICE WOULD NOT ADVANCE AND WAS STUCK IN THE REAMER BULLET WHILE IN USE TOGETHER. IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO REMOVE THE PIN. IT WAS REPORTED THAT THE SURGEON HAD TO FREEHAND DRILLED THE PASSING PIN TO COMPLETE THE PROCEDURE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS STUCK AND COULD NOT BE REMOVED. 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 16421110 ↗