NA 03.404.001SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982274229), received between May 27, 2021 and Dec 5, 2025 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryDec 5, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED: A 43-YEAR-OLD PATIENT WITH A 16-YEAR HISTORY OF CHRONIC OSTEOMYELITIS OF THE RIGHT FEMUR WAS HOSPITALIZED ON (B)(6) 2025, DUE TO PAIN AND A NON-ACTIVE FISTULA; AT THE TIME OF THE PROCEDURE, THE PATIENT WAS IN GOOD CONDITION BUT HAD POOR PAIN CONTROL, WITH A FISTULA SHOWING RELUCTANCE, FLUSHING, EDEMA, AND ERYTHEMA, WITHOUT FEVER OR OTHER SYMPTOMS. THE SURGICAL PLAN WAS TO WASH THE RIGHT INTRAMEDULLARY CANAL; HOWEVER, DURING ASSEMBLY OF THE RIA 2 SYSTEM, A SALINE LEAK OCCURRED. MILLING WAS INITIATED USING SYNREAM AND MANUAL CUTTERS, FOLLOWED BY PASSAGE OF THE RIA WITH A 15 MM MILLING HEAD. DURING REAMING, THE RIA HOSE BECAME BLOCKED, AND THE PATIENT SUFFERED CARDIAC ARREST REQUIRING CARDIOPULMONARY RESUSCITATION. DUE TO INABILITY TO REMOVE THE TRAPPED HOSE, AN URGENT SUBTROCHANTERIC OSTEOTOMY WAS PERFORMED. POST-PROCEDURE REVIEW REVEALED THE SHAFT FUSED WITH THE HOSE. THE PATIENT WAS PLACED ON ECMO AND TRANSFERRED TO THE ICU, LATER REFERRED TO SHAIO CLINIC IN BOGOTÁ. ECMO WAS DISCONTINUED AFTER THREE DAYS; BRAIN MRI REVEALED CEREBRAL EMBOLISM, AND THE PATIENT SUBSEQUENTLY DIED AT SHAIO CLINIC.

  Patient problems: Cardiac Arrest; Embolism/Embolus

  MAUDE report 23729571 ↗
• MalfunctionMay 29, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, A RIA2 REAMING TUBE ASSEMBLY WAS SHOWN TO EXHIBIT DAMAGE AFTER THE CONCLUSION OF THE CASE. NO INDICATION WAS GIVEN AS TO WHETHER THE ISSUE AROSE DURING THE USAGE IN THE CASE OR AFTER WHEN DISASSEMBLY OCCURRED. BILATERAL INTRAMEDULLARY NAILING OF TIBIAS. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22107249 ↗
• MalfunctionMay 22, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY, WHILE REAMING THE MEDULLARY CANAL WITH THE 13 MM REAMER, THE RIA SYSTEM CAME OFF THE FLEXIBLE SHAFT. THE SPECIALIST HELD IT AND CONTINUED REAMING WITHOUT ANY PROBLEMS. UPON FINISHING THE REAMING, IT WAS EVIDENT THAT THERE WERE BLUE REMAINS AROUND THE SHAFT, APPARENTLY FROM THE RIA SYSTEM, WHICH HAD APPARENTLY MELTED. DUE TO THE AFOREMENTIONED, THERE WAS NO DISCOMFORT FOR THE DOCTOR; THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT ANY PROBLEMS FOR THE PATIENT AND WITHOUT ALTERATIONS IN SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22068857 ↗
• MalfunctionNov 11, 2024Break; Break

  IT WAS REPORTED THAT DURING A BONE HARVESTING PROCEDURE ON A PROXIMAL TIBIA NON-UNION USING THE RIA2 SYSTEM, THE TUBE ASSEMBLY ENCOUNTERED RESISTANCE AT THE NON-UNION SITE, NECESSITATING ADDITIONAL FORCE TO EXTRACT IT FROM THE CANAL. UPON REMOVAL, IT WAS OBSERVED THAT THE TUBE ASSEMBLY HAD SUSTAINED DAMAGE, WITH A CLEAN CUT APPROXIMATELY 3-4 CM FROM THE REAMER HEAD COUPLING POINT. A REPLACEMENT TUBE ASSEMBLY WAS IMMEDIATELY AVAILABLE, AND THE PROCEDURE CONTINUED. HOWEVER, THIS NEWLY OPENED TUBE ASSEMBLY ALSO BECAME LODGED AT THE NON-UNION SITE, REQUIRING FURTHER PULLING TO DISENGAGE IT FROM THE SURROUNDING BONE FRAGMENTS. UNFORTUNATELY, THIS SECOND TUBE ASSEMBLY WAS FOUND TO BE MORE SEVERELY DAMAGED, RESULTING IN MULTIPLE FRAGMENTS. DESPITE THESE CHALLENGES, THE BONE HARVESTING PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THE CASE PROCEEDED AS PLANNED. SURGERY WAS DELAYED 10 MINUTES DUE TO THE REPORTED EVENT AND THE PROCEDURE SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20659290 ↗
• MalfunctionSep 20, 2024Break; Entrapment of Device; Device-Device Incompatibility; Break; Entrapment of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 , DURING REAMING THROUGH SUPRAPATELLAR EXPERT SLEEVE BECAME CAUGHT AND PLASTIC PIECES WERE LEFT INSIDE PATIENT. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) RIA 2 REAMING KIT 520MM STERILE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20269907 ↗
• MalfunctionJul 5, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT HARDWARE REMOVAL AFTER RIGHT HUMERUS NON-UNION. DURING THE PROCEDURE, BONE HARVEST CLOGGED INTO THE ASSEMBLY. THE RAI 2 SHAFT WAS STUCK INSIDE THE ASSEMBLY; THE PLASTIC WAS CUT AWAY FORM THE SHAFT. THIS REPORT IS FOR AN RAI 2 REAMING KIT. THIS IS REPORT 4 OF 5 FOR (B)(4) CAPTURES THE INTRA-OPERATIVE RAI 2 ISSUES. RELATED COMPLAINT (B)(4) CAPTURES THE REQUIRED REVISION PROCEDURE DUE TO NON-UNION.

  Patient problems: Insufficient Information

  MAUDE report 19680357 ↗
• MalfunctionJan 30, 2024Break; Break

  THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18605010 ↗
• MalfunctionNov 27, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING AN UNKNOWN PROCEDURE SURGEON WAS REAMING WITH RIA2 KIT VIA A SUPRAPATELLAR APPROACH. AT SOME POINT THE PLASTIC SHAFT BROKE IN THE CANAL, LEADING TO PLASTIC FRAGMENTS IN THE CANAL WHICH WERE LATER REMOVED THROUGH AN ALREADY OPEN EXPOSURE. THIS REPORT IS FOR RIA 2 REAMING KIT 520MM STERILE FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18212043 ↗
• MalfunctionNov 27, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, SURGEON WAS REAMING WITH RIA2 VIA INFRAPATELLAR APPROACH. THE TIP OF THE PLASTIC SHAFT BECAME MANGLED AND HAD TO BE REPLACED BY ANOTHER STERILE KIT. THIS REPORT IS FOR RIA 2 REAMING KIT 520MM STERILE FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18210295 ↗
• MalfunctionMar 9, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A SURGERY, THE REAMER IRRIGATOR ASPIRATOR 2 REAMING KIT SYSTEM HAD A HOLE IN IT WHICH IS EITHER PREEXISTING HOLE IN THE TUBING OR THE TENSION ON THE TUBE ASSEMBLY CREATED A HOLE. THE REAMING KIT WAS OPENED TO COMPLETE THE SURGERY. 5 MINUTES SURGICAL DELAY. NO FRAGMENTS GENERATED. NO PATIENT OUTCOME. THIS COMPLAINT INVOLVES ONE (1) DEVICE RIA 2 REAMING KIT 520MM STERILE. THIS REPORT IS FOR ONE (1) (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13713668 ↗
• MalfunctionMay 27, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE RIA 2 BONE HARVESTING KIT, 520MM SUCTION TUBING SHAFT DISCONNECTED FROM THE METAL COUPLING DISTALLY. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) RIA 2 REAMING KIT 520MM STERILE. THIS REPORT IS 1 OF 1 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893329 ↗