NA 03.404.026SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982273956), received between Jun 2, 2020 and Dec 5, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 19, 2020Class IITerminated

   RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed

   Z-0581-2021 · Root cause: Use error · Recall details · FDA record ↗

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.

• 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 23729474 ↗
• MalfunctionJul 21, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON WAS REAMING THE LEFT FEMORAL CANAL WITH RIA HEAD SIZE 15, AND THE REAMER HEAD SEPARATED FROM THE SHAFT. THE RIA WAS REMOVED FROM THE CANAL AND THE HEAD WAS UNABLE TO BE REUSED. TWO OUT OF THE FOUR PRONGS BROKE OFF. NO PATIENT HARM, A SECOND REAMER HEAD WAS OPENED TO COMPLETE THE PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANY SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE (1) 15.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370884 ↗
• InjuryMar 23, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT RIA 2 REAMER HEAD INTER TORCH FRACTURE. CASE INVOLVED RIA 2 BONE HARVEST, PART NO. 03.404.000S. WE USED A NO. OF REAMER HEAD LARGEST SIZE, PART NO. 03.404.026S - POST OPERATIVE HE HAD THAT FRACTURE. THIS COMPLAINT INVOLVES ONE (1) DEVICE 15.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 13861256 ↗
• MalfunctionJun 21, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 15.0MM REAMER HEAD FOR RIA 2 STERILE WAS RECEIVED BROKEN. THIS REPORT IS FOR ONE (1) 15.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032070 ↗
• InjuryMay 12, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, THERE WAS A TIBIAL SHAFT NON-UNION OF THE RIA 2 ON FEMUR DURING A BONE GRAFTING. THE REAMING ROD WAS PLACED INTO ONE OF THE CONDYLES OF THE DISTAL FEMUR, WHILE REAMING OVER THERE WAS A SLIGHT BENT. THE REAMER HEAD BROKE OFF ONTO THE REAMING ROD AND THE TIMES THAT HOLD THE REAMER HEAD TO THE TUBE ASSEMBLY WERE BROKEN OFF INTO THE PATIENT. REAMING ROD WAS THEN PULLED OUT AND THE TUBE ASSEMBLY WAS NOT DAMAGED. WE WERE ABLE TO ADD A NEW REAMING HEAD AND CONTINUE REAMING. THE SURGEON SAID HE DOES RIA 1 OVER BEND ALL THE TIME SO HE WAS SURPRISED WHEN IT BROKE OFF. ALSO TOLD ME THAT HE WAS GOING SLOW AND WAS NOT FORCING IT OVER THE SLIGHT CURVE IN THE REAMING ROD. TINY PIECES OF RIA 2 HEAD LEFT INSIDE THE PATIENT. CONCOMITANT DEVICE REPORTED: UNK - REAMING RODS: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: TIBIAL SHAFT UNKNOWN). UNK - REAMERS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 15.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11815698 ↗
• InjuryJun 2, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SPLINES OF A 15MM REAMER IRRIGATOR ASPIRATOR (RIA) 2 HEAD SHEARED OFF IN A PATIENT FEMORAL CANAL WHILE USING RIA 2 FOR BONE HARVESTING. FRAGMENTS WERE GENERATED FROM A BROKEN DEVICE, BUT THE SMALL PIECES WERE LEFT IN THE FEMORAL CANAL AS THE INTRAMEDULLARY NAIL WAS PLACED. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN RIA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10112645 ↗