NA 03.404.024SRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982274069), received between Jul 20, 2020 and Jan 28, 2025 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (14 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-0579-2021 · Root cause: Use error · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2025Break; Entrapment of Device; Device-Device Incompatibility; Break; Entrapment of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025. USING RIA 2 FOR BONE GRAFT, THE SURGEON PLACED THE ENTRY GUIDE WIRE FAR LATERAL ON THE GREATER TROCHANTER AT AN ANGLE OF MUCH GREATER THAN 10 DEGREES TO THE FEMORAL CANAL. THE SALES CONSULTANT ADVISED THE SURGEON THAT THE SURGICAL TECHNIQUE RECOMMENDS A GREATER TROCH ENTRY POINT NO GREATER THAN 10 DEGREES OFF THE AXIS OF THE FEMORAL CANAL TO REDUCE STRAIN ON THE INSTRUMENT AND REDUCE THE RISK OF REAMING OUT MEDIAL. THE SURGEON SAID THEY KNEW, BUT WANTED TO USE THIS START POINT DUE TO PATIENT ANATOMY. THEY INSERTED THE RIA INTO THE FEMUR SPINNING AT ONLY HALF SPEED, THEN REAMED THE CANAL AT FULL DRILL SPEED. WHEN PULLING THE REAMER BACK, WE NOTICED THE RIA HEAD HAD DETACHED FROM THE REAMER SHAFT AND THERE WERE METAL FRAGMENTS IN THE FEMORAL CANAL. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FORTY-FIVE MINUTE DELAY. SURGEON TRIED TO REMOVE FRAGMENTS WITHOUT SUCCESS.

  Patient problems: Foreign Body In Patient

  MAUDE report 21254182 ↗
• MalfunctionOct 4, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, DOCTOR WAS HARVESTING BONE GRAFT IN THE FEMUR ANTEGRADE USING RIA 2 BONE HARVESTING KIT WITH 14.0MM RIA 2 REAMER HEAD WITH THE RIA 2 SHAFT WITH 2.5MM REAMING ROD THE 14MM RIA2 HEAD BROKE AT THE TINES WHEN THE REAMER WAS MIDSHAFT. THE REAMER HEAD WAS RETRIEVED BY PULLING THE 2.5M¿ GUIDE ROD. THE TINES OF THE REAMER HEAD WERE UNABLE TO BE RETRIEVED AND WERE LEFT IN IM CANAL. ORIF REVISION PROXIMAL ULNA. SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. THERE WAS PATIENT CONSEQUENCES REPORTED AS TINES OF REAMER LEFT IN IM CANAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 20371792 ↗
• MalfunctionJan 25, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED JANUARY 10, 2024 THE RIA 2 HEAD BROKE OFF IN PATIENT LEAVING METAL SHRAPNEL IN THE PATIENT. THE HEAD OF THE RIA 2 WAS ABLE TO BE REMOVED BUT THE PRONGS WERE LEFT IN. METAL WAS LEFT IN PATIENT FEMUR. THIS REPORT INVOLVES ONE (1) 14.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18582731 ↗
• MalfunctionJan 23, 2024Break; Entrapment of Device; Break; Entrapment of Device

  THIS COMPLAINT IS RELATED TO (B)(4) WHICH CAPTURES THE POST-OP EVENT OF ONE OF THE PROXIMAL SCREWS WAS BROKEN.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18565498 ↗
• MalfunctionSep 21, 2023Break; Break

  IT WAS REPORTED ON (B)(6) 2023, THAT WHILE REAMING THE FEMORAL CANAL OF A PATIENT WITH THE RIA 2 SYSTEM WE HEARD A SNAPPING NOISE. WHEN LOOKING ON FLUOROSCOPY IT WAS CLEAR THAT THE REAMER HEAD BROKE AND DETACHED FROM THE DRIVE SHAFT. THE SURGEON PULLED BACK THE BALL-TIP GUIDEWIRE WHICH WAS ABLE TO SUCCESSFULLY REMOVE THE BROKEN REAMER HEAD FROM THE CANAL. THERE APPEARED TO BE SOME SMALL PIECES OF DEBRIS LEFT IN THE CANAL. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY AND PROCEDURE COMPLETED SUCCESSFULLY, THERE WAS NO PATIENT OUTCOME. CONCOMITANT PRODUCT: UNK - SCREWDRIVERS: SHAFTS(PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). UNK - GUIDE/COMPRESSION/K-WIRES(PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 14.0MM 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 17789762 ↗
• InjuryFeb 23, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE RIA II SYSTEM, REAMER HEADS WERE BROKEN DURING THE REMOVAL OF SHAFT FROM THE PATIENT. AND LITTLE "WINGS" WERE LEFT IN THE CANAL. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 14.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 3 FOR COMPLAINT: (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16427718 ↗
• InjuryFeb 23, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE RIA II SYSTEM, REAMER HEADS WERE BROKEN DURING THE REMOVAL OF SHAFT FROM THE PATIENT. AND LITTLE "WINGS" WERE LEFT IN THE CANAL. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 14.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16427715 ↗
• MalfunctionNov 9, 2022Break; Break

  IT WAS REPORTED THAT THE SURGEON REMOVED A NON-SYNTHES TIBIAL NAIL THAT HAD BECOME INFECTED ON (B)(6), 2022. DURING THE PROCEDURE, WHILE PUSHING A NEW SHAFT DOWN THE TIBIA, THE REAMER HEAD CAME OFF. THE SURGEON TOOK THE TIP OFF THE BALL AND REAMER BACK OFF AND CONTINUED THE PROCEDURE. THERE WAS A MINOR SURGICAL DELAY RELATED TO REATTACHMENT OF THE REAMER HEAD AND ATTEMPT TO FLUSH SMALL DEBRIS WITH THE RIA2. THE PATIENT STATUS WAS REPORTED AS: INFECTED TISSUE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE GRAFT FILTER F/RIA 2. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15762225 ↗
• InjuryMar 11, 2022Entrapment of Device; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A SCHEDULED TRANSPLANT OPERATION BONE MARROW, THE PRACTITIONER USED AN RIA KIT 2 (BORING, IRRIGATION, SUCTION) IN FRAME MASKLET'S TECHNIQUE. DURING THE PROCEDURE THE FINS OF THE HEADS, BORE SIZES OF 10, 10.5, 11 AND 14 MM, BROKE IN THE DISTAL THIRD OF THE FEMUR DESPITE USE OF THE DEVICE IN ACCORDANCE WITH SUPPLIER'S RECOMMENDATIONS. THE 16 BROKEN FINS ENDED UP IN INTRAOSSEOUS. THE PRACTITIONER WAS ABLE TO REMOVE ABOUT HALF OF THE FINS OF THE BORING HEADS; HOWEVER, PARTS REMAIN IN THE FEMUR DESPITE NUMEROUS RECOVERY ATTEMPTS. THERE WAS A SURGICAL DELAY OF FORTY-FIVE (45) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE (1) REAMER. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13732050 ↗
• MalfunctionFeb 10, 2022Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE REAMER HEADS FOR REAMER IRRIGATOR ASPIRATOR (RIA) 2 BROKE OFF WHILE HARVESTING BONE GRAFT FROM THE LEFT FEMUR. X-RAY CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TEN MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 14.0MM 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 13509601 ↗
• MalfunctionJan 12, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE REAMER IRRIGATOR ASPIRATOR (RIA) 2 REAMER HEAD BROKE IN THE PATIENT WHILE USING RIA IN THE DISTAL FEMUR. FRAGMENTS WERE GENERATED AND LATER RETRIEVED WITH A LONG GRASPING DEVICE. THERE WERE (10) MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR (1) 14.0MM 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 13238901 ↗
• MalfunctionDec 3, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A SURGICAL PROCEDURE, A REAMER HEAD BROKE OFF OF DRIVE SHAFT WHILE REAMING. IT WAS REPLACED WITH A SMALLER DIAMETER REAMING HEAD. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 14.0MM 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 12924553 ↗
• MalfunctionMay 28, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE REAMER IRRIGATOR ASPIRATOR (RIA) 2 REAMER SHAFT AND REAMER HEAD CONNECTION TABS BROKE DURING REAMING AND ALSO COULD NOT REMOVE RIA 2 FLEX REAMER SHAFT FROM THE DISPOSABLE RIA 2 SHAFT. THE SURGERY WAS DELAYED FOR 7-10 MINUTES. FRAGMENTS REMOVED. USED OTHER SHAFT TO COMPLETE REAMING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1)14.0MM REAMER HEAD FOR RIA 2 STERILE THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904571 ↗
• MalfunctionOct 19, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, THE REAMER/IRRIGATOR/ASPIRATOR (RIA) 2 TIP BROKE OFF DURING INSERTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A 14.0MM REAMER HEAD FOR RIA 2. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10696806 ↗
• MalfunctionJul 20, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. AFTER THE BONE GRAFT WAS TAKEN AS THE SURGEON WAS PULLING THE REAMER IRRIGATOR ASPIRATOR (RIA 2) OUT OF THE FEMORAL CANAL, THE REAMER HEAD HAD BEEN DISCONNECTED FROM THE RIA 2 ASSEMBLY. THE REAMER HEAD BROKE OFF OF THE ASSEMBLY. THE SURGEON WAS ABLE TO RETRIEVE THE PART FROM THE PATIENT BY REMOVING THE REAMING RODS WITH BALL TIP. NO PIECES WERE RETAINED, AND THE BONE GRAFT WAS SUCCESSFULLY HARVESTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT STATUS WAS STABLE AS EXPECTED. CONCOMITANT DEVICE REPORTED: REAMER IRRIGATOR ASPIRATOR (RIA 2) BONE HARVESTING KIT (PART NUMBER 03.404.000S, LOT 52P8570, QUANTITY 1), REAMING RODS WITH BALL TIP (PART NUMBER 351.708S, LOT 32P9883, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 14.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10297753 ↗