RIGIDLOOP 232460Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886705026494), received between Sep 8, 2021 and Sep 20, 2023 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2023Break; Break

  THIS IS REPORT 4 OF 4 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN FINLAND THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RIGIDLOOP COMBO REAMER/PASSING PIN - ARROW TIP (10-160MM +/- 0.1MM) 4.5MM DEVICE BROKE WHILE DRILLING IN A STRAIGHT LINE ACROSS THE SHAFT; AND APPROXIMATELY IN THE SECTION OF THE FIRST MEASURING LINE UNDER THE BLADE. 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 17782999 ↗
• MalfunctionSep 20, 2023Break; Break

  THIS IS REPORT 1 OF 4 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN FINLAND THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RIGIDLOOP COMBO REAMER/PASSING PIN - ARROW TIP (10-160MM +/- 0.1MM) 4.5MM DEVICE BROKE WHILE DRILLING IN A STRAIGHT LINE ACROSS THE SHAFT; AND APPROXIMATELY IN THE SECTION OF THE FIRST MEASURING LINE UNDER THE BLADE. 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 17782990 ↗
• MalfunctionSep 20, 2023Break; Break

  THIS IS REPORT 3 OF 4 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN FINLAND THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RIGIDLOOP COMBO REAMER/PASSING PIN - ARROW TIP (10-160MM +/- 0.1MM) 4.5MM DEVICE BROKE WHILE DRILLING IN A STRAIGHT LINE ACROSS THE SHAFT; AND APPROXIMATELY IN THE SECTION OF THE FIRST MEASURING LINE UNDER THE BLADE. 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 17782989 ↗
• MalfunctionSep 20, 2023Break; Break

  THIS IS REPORT 2 OF 4 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN FINLAND THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RIGIDLOOP COMBO REAMER/PASSING PIN - ARROW TIP (10-160MM +/- 0.1MM) 4.5MM DEVICE BROKE WHILE DRILLING IN A STRAIGHT LINE ACROSS THE SHAFT; AND APPROXIMATELY IN THE SECTION OF THE FIRST MEASURING LINE UNDER THE BLADE. 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 17782985 ↗
• MalfunctionSep 20, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN FINLAND THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RIGIDLOOP COMBO REAMER/PASSING PIN - ARROW TIP (10-160MM +/- 0.1MM) 4.5MM DEVICE BROKE WHILE DRILLING IN A STRAIGHT LINE ACROSS THE SHAFT; AND APPROXIMATELY IN THE SECTION OF THE FIRST MEASURING LINE UNDER THE BLADE. 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 17782955 ↗
• MalfunctionAug 8, 2022Break; Break

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN GERMANY THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THREE RIGIDLOOP 4.5MM COMBO REAMER/PASSING PIN ¿ ARROW TIP DEVICE BROKE IN-SITU. NO PARTS REMAINED IN THE PATIENT. 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 15188208 ↗
• MalfunctionAug 8, 2022Break; Break

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN GERMANY THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THREE RIGIDLOOP 4.5MM COMBO REAMER/PASSING PIN ¿ ARROW TIP DEVICE BROKE IN-SITU. NO PARTS REMAINED IN THE PATIENT. 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 15188129 ↗
• MalfunctionAug 8, 2022Break; Break

  THIS IS REPORT 3 OF 3 FOR (B)(4).IT WAS REPORTED BY THE AFFILIATE IN GERMANY THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THREE RIGIDLOOP 4.5MM COMBO REAMER/PASSING PIN ¿ ARROW TIP DEVICE BROKE IN-SITU. NO PARTS REMAINED IN THE PATIENT. 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 15188080 ↗
• MalfunctionJul 6, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN GERMANY THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE RIGIDLOOP 4.5MM COMBO REAMER/PASSING PIN DEVICE BROKE OFF WHILE DRILLING. THE BROKEN TIP WAS TAKEN OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14937156 ↗
• MalfunctionJan 13, 2022Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4.5 LONGER TIP BEATH PIN DEVICE BROKE. THERE WERE NO FRAGMENTS GENERATED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252805 ↗
• InjurySep 8, 2021Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ARTHROSCOPY ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TIP ON THE 4.5 LONGER TIP BEATH PIN DEVICE WAS BROKEN. THERE WERE FRAGMENTS GENERATED; THEREFORE, TWO X-RAYS WERE NECESSARY TO REMOVE ALL THE FRAGMENTS. THERE WAS A SURGICAL DELAY OF 10 MINUTES. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12439446 ↗