NA 03.404.035Recalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 10886982274243), received between May 1, 2020 and Sep 22, 2026 — classified as 21 injuries, 92 malfunctions.

The most frequently reported specific device problem is “Break” (107 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 25 most recent of 113 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860231 ↗
• MalfunctionAug 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50418726 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT SYNREAM REAMING ROD Ø2.5 LONG L1150, DRIVE SHAFT F/RIA 2 L520, AND SYNREAM REAMING ROD Ø2.5 SHORT L950 WERE INVOLVED IN AN INTRAOPERATIVE EVENT. DURING SURGERY, THE RIA TREE BROKE WHILE TAKING THE GRAFT, AND THE OLIVE-SHAPED GUIDES BENT AND WERE MARKED. SEVERAL GUIDES AND EQUIPMENT WERE NOT PROVIDED BY THE CENTRAL STAFF, AND A MISSING BOX WAS REPORTED. THERE WAS UNCERTAINTY REGARDING THE STERILIZATION STATUS OF THE SYNREAM EQUIPMENT USED EARLIER THAT DAY, AND THE MOTOR HANDLES WERE NOTED TO BE LOOSE. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071693 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT AT THE TIME OF REAMING, THE DRIVE SHAFT RIA FATIGUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019754 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT THE DRIVE SHAFT FOR RIA 2 520MM SNAPPED IN HALF AND BROKE OFF AT THE TIP DURING INTRAOPERATIVE USE WHILE REAMING THE TIBIA. THERE WAS NO REPORTED PATIENT HARM OR USER INJURY, BUT THE INCIDENT RESULTED IN A SIGNIFICANT SURGICAL DELAY OF APPROXIMATELY 15¿20 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729717 ↗
• MalfunctionMar 17, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DRIVE SHAFT FOR RIA 2 520MM AND RIA 2 BONE HARVESTING KIT L520 WERE INVOLVED IN AN EVENT. DURING DISASSEMBLY OF THE RIA2 DRIVE SHAFT FROM THE DISPOSABLE COMPONENT, THE YELLOW DRIVE SEAL WAS FOUND DAMAGED, AND THE BLUE PORTION OF THE TUBE ASSEMBLY WAS BROKEN, WITH PART OF THE DISPOSABLE PIECE STUCK ONTO THE DRIVE SHAFT AND UNABLE TO BE REMOVED. THE PROCEDURE WAS CARRIED OUT ACCORDING TO THE SURGICAL TECHNIQUE WITHOUT ISSUES. BOTH PRODUCTS REQUIRED REPLACEMENT. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615548 ↗
• MalfunctionMar 12, 2026Break

  IT WAS REPORTED THE SURGEON FORCED THE DRIVE SHAFT TOO HARD; IT FRACTURED INTO TWO PIECES DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579665 ↗
• MalfunctionJan 14, 2026Break; Corroded; Material Discolored

  IT WAS REPORTED THAT GRAPHICS CASES AND INSTRUMENTS ARE CHIPPING AND SHOWING SIGNS OF CORROSION OR WEAR AND BREAKING DOWN SO THE CSPD DEPARTMENT REFUSES TO REPROCESS THEM. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066455 ↗
• MalfunctionJan 13, 2026Break; Corroded; Material Discolored

  IT WAS REPORTED THAT GRAPHICS CASES AND INSTRUMENTS ARE CHIPPING AND SHOWING SIGNS OF CORROSION OR WEAR AND BREAKING DOWN; THE CSPD DEPARTMENT REFUSES TO REPROCESS THEM. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053644 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT THE DRIVE SHAFT F/RIA 2 L520 WAS BROKEN INTRAOPERATIVELY. THE UPPER PART OF THE DRIVESHAFT BROKE OFF DURING USE, AND ONLY A PORTION OF THE DEVICE WAS RETURNED AS A PHOTO FOR EVALUATION. AS A RESULT OF THE DEVICE FAILURE, ONLY ONE-THIRD OF THE INTENDED BONE MARROW COULD BE HARVESTED, NECESSITATING ADDITIONAL BONE MARROW REMOVAL FROM THE PELVIC CREST. THIS COMPLICATION PROLONGED AND COMPLICATED THE SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840473 ↗
• 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 (B)(6). ECMO WAS DISCONTINUED AFTER THREE DAYS; BRAIN MRI REVEALED CEREBRAL EMBOLISM, AND THE PATIENT SUBSEQUENTLY DIED AT (B)(6).

  Patient problems: Cardiac Arrest; Embolism/Embolus

  MAUDE report 23729850 ↗
• MalfunctionDec 4, 2025Break; Break

  IT WAS REPORTED THAT A DRIVE SHAFT RIA 2 WAS DAMAGED DURING THE PROCEDURE. ALL STEPS WERE FOLLOWED, AND THE DOCTOR CORRECTLY USED ALL THE NECESSARY COMPONENTS BEFORE USING THE RIA, SUCH AS THE SYNREAM. DESPITE THIS, THE SHAFT BROKE. NEVERTHELESS, THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY ADVERSE EFFECTS ON THE PATIENT, OR ALTERATIONS TO THE SURGICAL SCHEDULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23719886 ↗
• MalfunctionDec 2, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INSPECTION IT WAS IDENTIFIED THAT THERE ARE DAMAGES AROUND THE END OF THE DRIVE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693771 ↗
• MalfunctionDec 2, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INSPECTION IT WAS IDENTIFIED THAT THERE ARE DAMAGES AROUND THE END OF THE DRIVE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693764 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED ON (B)(6) 2025 THAT RIA 2 SHAFT BROKE. IT IS NOT KNOWN IF THE PATIENT EXPERIENCED AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. IT IS UNKNOWN IF THE PATIENT REQUIRED REVISION SURGERY OR HARDWARE REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606809 ↗
• MalfunctionAug 27, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE RIA 2 DRIVE SHAFT WAS STUCK IN THE TIBIA AND WAS PUSHED AND BROKEN BY OVERHEATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907290 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE RIA HARVESTING KIT BROKE AT THE PLASTIC TIP JUNCTION NEAR THE RIA HEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153571 ↗
• MalfunctionMay 13, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. NO SURGICAL DELAYS.

  Patient problems: Insufficient Information

  MAUDE report 22009073 ↗
• MalfunctionMar 3, 2025Break; Break

  IT WAS REPORTED THAT THE RIA SHAFT TIP WAS BROKE OFF AFTER REAMING. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. FRAGMENTS WERE NOT GENERATED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21505714 ↗
• MalfunctionMar 3, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE RIA 2 HEAD BROKE DURING REAMING AND THE DRIVE SHAFT COULD ALSO BE BROKEN. IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES/OUTCOMES.

  Patient problems: Insufficient Information

  MAUDE report 21503313 ↗
• MalfunctionFeb 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A CASE ON THE (B)(6) 2025 WHEN THE BONE HARVESTING KIT FOR RIA 2 WAS USED, IT WAS NOTICED THAT THE PLASTIC WAS COILING WHILE REAMING WITH THE GUIDANCE OF X-RAY. THE INSTRUMENT WAS EXAMINED AND IT WAS NOTED THAT THE PARTICULAR YELLOW COLORED PLASTIC ATTACHMENT HAD BURST INSIDE THE INSTRUMENT HENCE CAUSING IT TO NOT WORK PROPERLY. WHEN TRIED TO DISASSEMBLE AT THE END OF THE OPERATION, THE DAMAGED PLASTIC HAD GOTTEN STUCK TO THE INSTRUMENT AND COULD NOT BE REMOVED. ANOTHER SEPARATELY PACKED REAMING KIT WAS OPENED AND USED.

  Patient problems: Insufficient Information

  MAUDE report 21437062 ↗
• MalfunctionFeb 3, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 THE RIA SHAFT TIP BROKE WHILE REAMING A TIBIA AT THE HOSPITAL. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21298304 ↗
• MalfunctionJan 17, 2025Break; Break

  IT WAS REPORTED THAT SHAFT TIP WAS BROKEN OFF AND IT WAS FOUND IN SPD.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179529 ↗
• MalfunctionJan 17, 2025Break; Break

  IT WAS REPORTED THAT SHAFT TIP WAS BROKEN OFF AND IT WAS FOUND IN SPD.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179417 ↗
• MalfunctionNov 25, 2024Break; Break

  IT WAS REPORTED THAT THE YELLOW ROD SEAL WAS STILL ATTACHED TO THIS ITEM DURING STERILIZATION, THE ROD SEAL MELTED IN ITEM AND THE INSTRUMENT COULDN'T BE USED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20774845 ↗