RIGIDLOOP 232028Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705022755), received between Feb 28, 2022 and Mar 6, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Degraded” (2 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.

• MalfunctionMar 6, 2026Material Deformation

  IT WAS REPORTED THAT THE ACL DRILLPN W/EYE .094X14 DEVICE AND RIGIDLOOP REAMER 4.5MM DEVICE WERE DEFECTIVE; BENT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WERE NO REPORTS OF SURGICAL DELAY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24534689 ↗
• MalfunctionFeb 11, 2025Degraded; Degraded

  IT WAS REPORTED THAT WHILE PERFORMING AN ANTERIOR CRUCIATE LIGAMENT TECHNIQUE, DURING THE BROCADE OF THE TIBIA, A DRILL BIT DEVICE OF TIBIA WAS USED WITH THE RESTORE FULL FLUTE REAM DEVICE WHICH WAS INEFFICIENT AND THE ASSISTANT SPECIALIST HAD TO EXERT MORE FORCE TO PERFORM THE TUNNEL AND IN TURN. A LOT OF DELAY OCCURRED DURING THIS STEP, THE STATE OF THE MOTOR AND BATTERY WERE VERIFIED TO RULE OUT FAILURES OF THE POWER EQUIPMENT. SATISFACTORY TO THE ASSESSMENT IN TERMS OF FORCE AND SPEED, THIS BEING RULED OUT AS CAUSAL. THE PROCESS TAKES LONGER THAN USUAL TO CROSS THE METAPHYSIS AND EFFECTIVELY PERFORATE THE ARTICULAR CORTEX OF THE TUNNEL, THE TIP OF THE BUTTONHOLE PIN WAS PROTECTED WITH A CURETTE, HOWEVER, THE FORCE ADMINISTERED TO BE ABLE TO PIERCE THE ARTICULAR CORTEX MUST BE SO MUCH THAT AT THE EXIT OF THE JOINT. IT WAS IMPOSSIBLE TO CONTROL THAT THE DRILL BIT WAS NOT AT THE END OF THE JOINT. THIS IS REPORT 1 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21357949 ↗
• MalfunctionSep 15, 2024Inaccurate Information; Inaccurate Information

  THIS IS REPORT 9 OF 10 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT THE LOT NUMBER ON THE LABEL ON THE RIGIDLOOP REAMER 4.5MM DEVICE WAS NOT CONSISTENT WITH THE LOT NUMBER THAT WAS ETCHED ON IT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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 20220915 ↗
• MalfunctionMay 20, 2024Degraded; Illegible Information; Degraded; Illegible Information

  IT WAS REPORTED BY THE SALES REP IN COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE TENDON HARV CLOSED STRIPPER EA DEVICE AND RIGIDLOOP REAMER 4.5MM DEVICE DRILL DID NOT CUT AND THE LASER MARKS WERE NO LONGER VISIBLE ON THE DRILL AND THE DOCTOR LIKED TO USE THE DRILL TO MEASURE THE DEPTH OF THE FIRST FEMORAL TUNNEL FOR THE PASSAGE OF THE RIGID LOOP PLATE. THERE WERE NO REPORTS OF ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 OF THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352340 ↗
• MalfunctionJul 26, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT THE RIGIDLOOP CANNULATED REAMER 4.5MM DEVICE WAS MISSING FROM THEIR CONSIGNMENT SET. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398251 ↗
• MalfunctionFeb 28, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE RIGIDLOOP REAMER 4.5MM DEVICE BROKE. ALL THE BROKEN FRAGMENTS WERE REMOVED. 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 13623338 ↗