RIGIDLOOP 232037Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705022830), received between Oct 8, 2019 and Jul 18, 2025 — classified as 1 injury, 5 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2025Break; Break

  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. 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 22542342 ↗
• MalfunctionMay 30, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE PACKAGE OF THE RIGIDLOOP DISPOSABLE KIT DEVICE HAD A HOLE IN IT WHICH RESULTED IT NOT BEING STERILE. 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 17023573 ↗
• InjuryDec 16, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RIGIDLOOP DISPOSABLES SYSTEM DEVICE WAS BROKEN INTO TWO PIECES. THE SURGEON DID A KNEE SCOPE TO REMOVE THE WIRE AND WAS ABLE TO REMOVE ONE PIECE. THE SECOND PIECE MIGRATED UP INTO THE FEMORAL TUNNEL AND THE DOCTOR DETERMINED THAT IT WAS BEST TO LEAVE THE WIRE. THE STATUS OF THE PATIENT POSTOPERATIVELY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13020339 ↗
• MalfunctionDec 28, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT WHILE USING GUIDEWIRE 1.1MM X 15 BROKE AND RIGIDLOOP DISPOSABLE KIT, A NITINOL WIRE WAS FOUND TO BE BROKEN AFTER ADVANCING SCREW IN. INTERVENTIONAL IMAGING WAS DONE TO RETRIEVE BROKEN PART OF THE WIRE. BROKEN WIRE WAS RETRIEVED SUCCESSFULLY. NO FRAGMENT LEFT IN PATIENT. THERE WAS A SURGICAL DELAY OF 15 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11082253 ↗
• MalfunctionOct 8, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE WHEN USING THE BEATH PIN IN THE CUSTOMER'S RIGIDLOOP DISPOSABLE SYSTEM METAL SHAVINGS WERE CREATED. THE SURGEON STOPPED USING THE PIN AND REMOVED THE METAL SHAVINGS WITH THE SUCTION FROM THE SHAVER. THE SURGEON OPENED ANOTHER RIGIDLOOP DISPOSABLE SYSTEM STARTED TO USE THE BEATH PIN AND HALFWAY INTO USING THE PIN IT WAS NOTICED THAT METAL SHAVING WERE CREATED. THIS IS WHEN THEY REALIZED THAT THE CUSTOMER'S ANTEROMEDIAL FEMORAL AIMER 6.5MM THAT WAS BEING USED WITH THE PINS HAS A SPUR ON IT CAUSING THE PINS TO CREATE METAL SHAVINGS. THE SURGEON REMOVED THE METAL SHAVINGS AGAIN WITH THE SUCTION FROM THE SHAVER. THE PROCEDURE WAS COMPLETED WITH ANOTHER AIMER AND THE SECOND DISPOSABLE SYSTEM. THERE WAS NO PATIENT HARM BUT THERE WAS A FIVE MINUTE SURGICAL DELAY TO THE CASE. THE SALES REP CONFIRMED THAT THERE WAS NO DEBRIS LEFT IN THE PATIENT. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE AIMER. THE DISPOSABLE SYSTEMS WERE DISCARDED BY THE CUSTOMER BUT THE AIMER WILL BE RETURNING FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 9169087 ↗
• MalfunctionOct 8, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE WHEN USING THE BEATH PIN IN THE CUSTOMER'S RIGIDLOOP DISPOSABLE SYSTEM METAL SHAVINGS WERE CREATED. THE SURGEON STOPPED USING THE PIN AND REMOVED THE METAL SHAVINGS WITH THE SUCTION FROM THE SHAVER. THE SURGEON OPENED ANOTHER RIGIDLOOP DISPOSABLE SYSTEM STARTED TO USE THE BEATH PIN AND HALFWAY INTO USING THE PIN IT WAS NOTICED THAT METAL SHAVING WERE CREATED. THIS IS WHEN THEY REALIZED THAT THE CUSTOMER'S ANTEROMEDIAL FEMORAL AIMER 6.5MM THAT WAS BEING USED WITH THE PINS HAS A SPUR ON IT CAUSING THE PINS TO CREATE METAL SHAVINGS. THE SURGEON REMOVED THE METAL SHAVINGS AGAIN WITH THE SUCTION FROM THE SHAVER. THE PROCEDURE WAS COMPLETED WITH ANOTHER AIMER AND THE SECOND DISPOSABLE SYSTEM. THERE WAS NO PATIENT HARM BUT THERE WAS A FIVE MINUTE SURGICAL DELAY TO THE CASE. THE SALES REP CONFIRMED THAT THERE WAS NO DEBRIS LEFT IN THE PATIENT. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE AIMER. THE DISPOSABLE SYSTEMS WERE DISCARDED BY THE CUSTOMER BUT THE AIMER WILL BE RETURNING FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 9169077 ↗