NA 03.404.027SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982273994), received between Sep 23, 2021 and Sep 2, 2025 — classified as 1 injury, 5 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 16, 2026.

Recalls naming this device

1. Nov 19, 2020Terminated

   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-0582-2021 · 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.

• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT WAS PRESENTED WITH A NONUNION OF THE TIBIA. SURGEON OPTED TO USE RIA2 TO HARVEST GRAFT FROM FEMUR FOR THE NONUNION SITE. FEMUR WAS OPENED AND BALL TIP GUIDEWIRE WAS PLACED. FEMUR WAS SIZED. RIA2 HEAD 15.5 WAS OPENED. WHEN THE SURGEON STARTED REAMING IN THE PROXIMAL FEMUR, THE TINES BROKE OFF FROM THE RIA2 HEAD AND HEAD DISENGAGED FROM THE SHAFT. THE SURGEON HAD TO SPEND TIME FISHING OUT TINES FROM PROXIMAL FEMUR. ALL BROKEN PIECED WERE REMOVED. A NEW RIA2 HEAD WAS OPENED. SURGERY COMPLETED SUCCESSFULLY. THE SURGERY WAS DELAYED BY 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22939420 ↗
• MalfunctionJul 5, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  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 REAMER HEAD. THIS IS REPORT 2 OF 5 FOR (B)(4). (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 19680268 ↗
• MalfunctionJul 5, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  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 REAMER HEAD. THIS IS REPORT 1 OF 5 FOR (B)(4). (B)(4) CAPTURES THE INTRA-OPERATIVE RAI 2 ISSUES. RELATED COMPLAINT PC-001635445 CAPTURES THE REQUIRED REVISION PROCEDURE DUE TO NON-UNION.

  Patient problems: Insufficient Information

  MAUDE report 19680250 ↗
• MalfunctionJul 11, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, WHILE REAMING THE MEDULLARY CHANNEL THE TIPS OF THE REAMER SPLIT. THE SPECIALIST CHECKED WITH THE IMAGE INTENSIFIER AND CONFIRMED THAT ALL FRAGMENTS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 15.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298035 ↗
• MalfunctionApr 8, 2022Break

  IT WAS REPORTED ON (B)(6) 2022, THE PHYSICIAN WAS USING RIA 2 FOR THE BONE GRAFT PORTION OF THE PROCEDURE. REAMER'S HEAD BROKE FROM THE REAMER SHAFT. THE BROKEN REAMER HEAD WAS REMOVED AS IT WAS STILL ON BALL TIP GUIDEWIRE. AN X-RAY WAS USED DURING THE PROCEDURE TO SHOW THE ENTIRE REAMER WAS REMOVED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 15.5MM 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 14054029 ↗
• InjurySep 23, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6)AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR AN ANKLE NAIL SURGERY. RIA 2 WAS USED TO TAKE BONE MARROW FROM THE RIGHT HIP IN ORDER TO USE IT FOR THE ANKLE FUSION WITH THE USE OF THE TTC ANKLE FUSION NAIL. DURING THE SURGERY, THE REAMING HEAD BROKE IN 2 PARTS AND THE DRIVE SHAFT WAS DAMAGED. GENERATED FRAGMENTS ARE LEFT IN THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH 15-MINUTES DELAY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 15.5MM REAMER HEAD FOR RIA 2 STERILE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12521236 ↗