NA 03.404.017SRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886982273949), received between Aug 12, 2020 and Apr 6, 2026 — classified as 6 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (15 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. How this data works · Data updated Oct 13, 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-0572-2021 · Root cause: Use error · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT RIA HEAD BROKE DURING TIBIAL NAIL CASE. HEAD WAS REMOVED WITH GUIDE WIRE BUT FRAGMENTS WERE LEFT. PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24792676 ↗
• MalfunctionAug 12, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, THE TINES ON RIA2 REAMER HEADS BROKE OFF IN THE IM CANAL TWICE DURING AN I&D FOR A TIBIA. A SECOND REAMER WAS OPENED TO FINISH, BUT THAT ALSO BROKE. STD FLEX REAMERS WERE USED TO FINISH THE CASE. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS GENERATION OF FRAGMENTS. ATTEMPTS WERE MADE TO REMOVE FRAGMENTS BUT FAILED. FRAGMENTS ARE STILL INSIDE THE PATIENT. ADDITIONAL X-RAYS WERE TAKEN DURING REMOVAL EFFORTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 22789310 ↗
• MalfunctionMay 12, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SPINES OF THE RIA TWO HEADS THAT ATTACH TO THE REAMER SHAFT SEPARATED FROM THE REAMER HEAD. THEY WERE STILL IN THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22002800 ↗
• MalfunctionSep 11, 2024Break; Break

  IT WAS REPORTED THAT ON AUGUST 23, 2024 BREAKAGE OF REAMER, POTENTIALLY FROM DAMAGE TO ACCOMPANYING SHAFT. THERE WAS A 30-MINUTE DELAY TO SURGERY TIME WHILE PATIENT UNDER ANESTHESIA FOR RETRIEVAL OF FRAGMENTS. NO ADVERSE EVENT FOR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189698 ↗
• MalfunctionJan 18, 2024Break; Entrapment of Device; Break; Entrapment of Device

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4). THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18536707 ↗
• MalfunctionDec 22, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023 WHILE USING THE RIA 2 SYSTEM IN A TIBIA, THE ATTACHMENT PRONGS ON THE RIA 2 HEADS BROKE OFF DURING REAMING AND WERE LEFT BEHIND IN THE PROXIMAL PART OF THE TIBIA. THIS HAPPENED TO TWO RIA 2 HEADS (A 10.5 MM AND 11.0 MM). THE BROKEN ATTACHMENT PRONGS WERE ABLE TO BE RETRIEVED FROM THE TIBIA USING LAPAROSCOPIC INSTRUMENTS. THERE WAS A SURGICAL DELAY OF 60 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ALL FRAGMENTS REMOVED. THIS REPORT IS FOR 10.5MM REAMER HEAD FOR RIA 2 STERILE FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18387410 ↗
• InjuryMay 23, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON WAS USING THE RIA 2 (REAMER IRRIGATOR ASPIRATOR) BONE HARVESTING KIT AND BITS THAT GO WITH IT. A PRODUCT REPRESENTATIVE WAS PRESENT FOR THE PROCEDURE TO ENSURE PROPER ASSEMBLY AND USE OF THE PRODUCT. DURING THE PROCEDURE, SHARDS OF THE BITS KEPT BREAKING OFF IN THE PATIENT¿S BONE AND WERE NOT ABLE TO BE RECOVERED. THIS ISSUE HAPPENED WITH ALMOST EVERY DEVICE USED IN THE PROCEDURE. WHEN THE KIT WAS BEING WITHDRAWN, PIECES OF WHAT LOOKED TO BE THE PLASTIC SHEATH SHREDDED AND TAKEN OUT OF THE INCISION. PER THE OR NOTE: WE ATTEMPTED TO START REAMING WITH THE 10 MM SYNTHES RIA, HOWEVER THE REAMER WOULD NOT PASS BEYOND THE LESSER TROCHANTER. THE RIA WAS REPLACED WITH AN 8.5 MM REAMER. THE REAMER WAS ADVANCED WITHOUT DIFFICULTY OVER THE BALL-TIPPED GUIDE ROD TO THE DISTAL FEMORAL PHYSIS. THE 10 MM RIA WAS AGAIN USED. THE REAMER WAS ADVANCED TO THE LEVEL OF THE DISTAL FEMORAL PHYSIS AND DURING EXTRACTION IT WAS NOTED THAT THE CUTTING HAD SEPARATED FROM THE REAMER, LEAVING 2 SMALL METAL TINES BEHIND IN THE FEMORAL DIAPHYSIS WHICH WERE IRRETRIEVABLE. A 10.5 MM RIA REAMER WAS ADVANCED TO PROXIMALLY THE MIDDLE OF THE DIAPHYSIS BEFORE THE REAMER

  Patient problems: Foreign Body In Patient

  MAUDE report 16987794 ↗
• MalfunctionMar 31, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023 THE NATIVE TIBIA WAS INFECTED TO USE THE RIA. THEY USED THREE DIFFERENT HEAD SIZES. ALL THREE HEAD SIZES WERE BROKE INSIDE THE BONE DURING USAGE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ONE HOUR SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 10.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659534 ↗
• InjuryJun 23, 2022Entrapment of Device; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, WHILE USING THE RIA 2, TO HARVEST BONE GRAFT FROM A GREATER TROCHANTERIC START POINT THE RIA HEAD BROKE OFF. THE BROKEN RIA HEAD WAS RETRIEVED WITH THE GUIDE ROD. FOUR METAL FRAGMENTS WERE RETAINED IN THE RIGHT FEMUR. WE THEN DROPPED DOWN A HALF A SIZE TO 10MM REAMER HEAD, FOLLOWED BY AN 11MM REAMER HEAD AND ,SUCCESSFULLY REAMED THE FEMUR AND OBTAINED THE NECESSARY BONE GRAFT. THERE WERE A SURGICAL DELAY OF 5 MINUTES. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - GUIDES/SLEEVES/AIMING: GUIDE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE(1) DEVICE 10.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 14786272 ↗
• MalfunctionFeb 3, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE REAMER HEAD ON THE RIA2 BROKE DURING REAMING TWICE. SEEM TO HAPPEN WHEN WE HIT THE POSTERIOR CORTEX OF THE TIBIA. TRIED A SECOND REAMER HEAD AND BROKE AGAIN. IT TOOK 20-30 MINUTES TO REMOVE FRAGMENTS OF THE REAMER HEAD FROM THE CANAL. THERE WERE 30 MINUTES SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 10.5MM REAMER HEAD FOR RIA 2 STERILE THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13440396 ↗
• MalfunctionFeb 3, 2022Break; Break

  IT WAS REPORTED THAT ON JANUARY 6, 2022, THE REAMER HEAD ON THE RIA2 BROKE DURING REAMING TWICE. SEEM TO HAPPEN WHEN WE HIT THE POSTERIOR CORTEX OF THE TIBIA. TRIED A SECOND REAMER HEAD AND BROKE AGAIN. IT TOOK 20-30 MINUTES TO REMOVE FRAGMENTS OF THE REAMER HEAD FROM THE CANAL. THERE WERE 30 MINUTES SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 10.5MM 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 13440395 ↗
• InjuryJul 15, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING A FEMORAL PROCEDURE DUE TO OSTEOMYELITIS INFARCTION, ONE (1) 10.5MM REAMER HEAD AND ONE (1) 11.0MM REAMER HEAD TINES WERE BROKEN AND EMBEDDED IN THE PATIENT. ONE (1) DRIVE SHAFT WAS BROKEN DURING REAMING. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN REAMING ROD (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: 1), UNKNOWN DRILL BITS (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 10.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12176885 ↗
• MalfunctionJun 25, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE FOR UNKNOWN REASON. WHILE REAMING THE FEMUR WITH A 10.5MM REAMER IRRIGATOR ASPIRATOR (RIA) 2 HEAD, THE HEAD BROKE OFF AND LEFT THE FOUR TABS IN THE FEMUR. THEN OPENED A 11.5 HEAD, AND IT BROKE THE SECOND OR THIRD IN AND OUT MOTION. THE SURGEON THEN PASSED REGULAR REAMER TO SIZE 11MM AND COMPLETED THE CASE WITH AN ADDITIONAL 11.5MM RIA 2 HEAD. CASE DELAYED BY 40 MINUTES. THE SURGEON RETRIEVE THE 8 METAL TABS THAT WERE LEFT FROM BROKEN HEADS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 40 MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1)10.5MM REAMER HEAD FOR RIA 2 STERILE. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12069551 ↗
• InjuryDec 10, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, WHILE REAMING A TIBIA WITH A REAMER HEAD FOR RIA 2 STERILE THE REAMER BECAME STUCK AND THE SURGEON WAS UNABLE TO PULL THE REAMER BACK. THE SURGEON FORCEFULLY PULLED THE REAMER BACK AND ONCE IT RELEASED IT WAS NOTICED THAT THE RIA2 SHAFT HAD TORN. FRAGMENTS WERE GENERATED AND WERE NOT REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION SINCE ONE FRAGMENT WAS LEFT IN THE TIBIA CANAL. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS UNKNOWN. CONCOMITANT DEVICES REPORTED: RIA 2 BONE HARVESTING KIT 520MM STERILE (PART NUMBER 03.404.000S, LOT 70P7750, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 10.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10985173 ↗
• InjuryNov 3, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS FURTHER REPORTED THAT THE EVENT IN QUESTION WAS A REVISION SURGERY TO REMOVE A NON-SYNTHES LARGE FRAG TYPE PLATE. A PIRIFORMIS RECON NAIL WAS IMPLANTED. INSERTION OF THE NAIL WAS PERFORMED WITH NO ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10779402 ↗
• InjuryAug 12, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING BONE GRAFTING ON (B)(6) 2020, THE 11.5MM AND 10.5MM REAMER/ IRRIGATOR/ ASPIRATOR (RIA 2) REAMER HEADS WERE SHEARED OFF IN THE CANAL AND LEFT INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN RIA 2 DRIVE SHAFT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 10.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10397008 ↗