NA 03.404.022SRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982274021), received between Mar 27, 2020 and Apr 6, 2026 — classified as 6 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (19 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-0577-2021 · Root cause: Use error · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT THE REAMER HEAD F/RIA 2 Ø13 BROKE OFF INTO THE PATIENT, AND NOT ALL FRAGMENTS WERE RETRIEVED. THE RIA 2 BONE HARVESTING KIT L520 ALSO BROKE, BUT ALL FRAGMENTS WERE RETRIEVED. THE DRIVE SHAFT F/RIA 2 L520 REQUIRED INSPECTION DUE TO CONTAMINATION, AND IT WAS UNCLEAR IF IT WAS BROKEN. THE EVENT DESCRIPTION INDICATES THAT THE REAMER HEAD F/RIA 2 Ø13 WAS EMBEDDED WITHIN THE PATIENT, WHILE THE RIA 2 BONE HARVESTING KIT L520 AND DRIVE SHAFT F/RIA 2 L520 WERE NOT ASSOCIATED WITH RETAINED FRAGMENTS. THERE WAS NO REPORTED PATIENT CONSEQUENCE OR INVOLVEMENT FOR ANY OF THE DEVICES.

  Patient problems: Foreign Body In Patient

  MAUDE report 24789469 ↗
• MalfunctionMay 13, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL HEAD OF THE RIA 2 WITH A DIAMETER OF 22 HAS SUFFERED A BREAK DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 22009041 ↗
• InjuryNov 20, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING SURGERY, 5 REAMER HEADS BROKE IN THE PATIENT'S FEMUR, LEAVING 20 METALLIC FRAGMENTS. THE FRAGMENT WERE UNABLE TO BE REMOVED. THE SURGERY WAS DELAYED 25 MINUTES. ANOTHER REAMER WAS USED AND WAS COMPLETED SUCCESSFULLY. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient; Unspecified Tissue Injury

  MAUDE report 20736235 ↗
• MalfunctionSep 23, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A BONE GRAFTING PROCEDURE ON (B)(6) 2024, WHILE REAMING WITH RIA 2, THE REAMER HEAD BROKE AND PART OF THE METAL REAMER HEAD WAS LEFT BEHIND IN PATIENT. THERE WAS NO SURGICAL DELAY. IT WAS REPORTED THAT THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20278576 ↗
• MalfunctionOct 31, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 10-SEPTEMBER-2023 DURING AN UNKNOWN PROCEDURE, THE RIA 2 COUPLING WORE OUT. TWO SEPARATE RIA 2 REAMER HEADS WERE DAMAGED DURING SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 13.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039473 ↗
• MalfunctionOct 31, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 DURING AN UNKNOWN PROCEDURE, THE TWO RIA 2 REAMER HEADS WERE DAMAGED. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 13.0MM 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 18039184 ↗
• 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 13.0MM 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 17298029 ↗
• MalfunctionJun 28, 2023Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, WHEN REMOVING THE RIA SHAFT AND REAMER FROM THE FEMUR, THE REAMER WINGLETS BROKE AND GOT STUCK IN THE YELLOW PLASTIC PIECE IN THE SHAFT, SO THE SURGEON COULD NOT PASS THROUGH THE REAMING BALL TIP GUIDE ANYMORE. THE SHAFT AND YELLOW PLASTIC PIECE HAD TO BE CHANGED. THIS REPORT INVOLVES ONE 13.0MM 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 17219331 ↗
• MalfunctionJun 2, 2023Break; Break

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PRIOR TO A PROCEDURE ON (B)(6) 2023, A REAMER/IRRIGATOR/ASPIRATOR (RIA) REAMER HEAD WAS FOUND BROKEN IN THE STERILE BAG AND WAS UNUSABLE FOR THE PROCEDURE. THE FINS WERE BROKEN. THIS REPORT IS FOR A 13.0MM 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 17049990 ↗
• MalfunctionApr 16, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, THE RIA2 REAMER HEAD BROKE WHILE REAMING LEFT TIBIA. RIA2 TUBE ASSEMBLY WAS DAMAGED WHEN REAMER HEAD FAILED. BOTH ITEMS WERE NO LONGER USABLE, NEW ITEMS WERE OPENED TO COMPLETE THE CASE. ATTENDING SPECULATION IS IT MAY HAVE BEEN DUE TO RESIDENT INADVERTENTLY STARTING TO REAM IN THE REVERSE DIRECTION. FRAGMENTS FROM REAMER HEAD WERE TOO DEEP TO REMOVE. THEY WERE RETAINED IN THE TIBIAL CANAL. THERE WAS A SURGICAL DELAY OF 10 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE IS NO INDICATION THAT THE DELAY RESULTED IN ANY IMPACT TO THE EXPECTED SURGICAL OUTCOME THIS REPORT IS FOR ONE (1) 13.0MM REAMER HEAD FOR RIA 2 STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748628 ↗
• InjurySep 23, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022 A NEW EVENT HAPPENED .IT INCLUDE 13MM REAR TOOL REAMER HEAD. THE REAMER HEAD BROKE INSIDE OF A TIBIA . IT DID INVOLVE THE PATIENT AND BREAK INTO 2 PIECES OF METAL. THERE WERE 3 FRAGMENTS AS A RESULT OF THE REAMER HEAD BREAKING. THE SURGEON WAS ABLE TO RETRIEVE 1 FRAGMENT, LEAVING THE OTHER 2 BEHIND IN THE TIBIA AS THEY WERE TO DIFFICULT TO RETRIEVE. THERE WAS A SURGICAL DELAY. REAMER HEAD OUT WAS CHANGED WITH NEW A REAMER HEAD AND ABLE TO ATTAIN THE BONE GRAFT. THE SURGERY WAS COMPLETED SUCCESSFULLY AFTER THE EVENT. THIS REPORT IS FOR ONE (1) 13.0MM REAMER HEAD FOR RIA 2 STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15470899 ↗
• MalfunctionDec 29, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A OPEN REDUCTION INTERNAL FIXATION (ORIF) OF RIGHT FEMUR PROCEDURE. IT WAS NOTED THAT DURING THE PROCEDURE WHEN USING THE RIA 2 WITH A 13MM REAMER HEAD, THE REAMER HEAD DETACHED FROM THE RIA 2 520MM DRIVE SHAFT. THE 4 TABS ON THE INSTRUMENTED END OF THE REAMER HEAD BROKE OFF AND HAD TO BE REMOVED FROM THE PATIENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 13.0MM 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 13113073 ↗
• MalfunctionNov 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE SUPERIOR TABS FOR THE REAMING HEAD FOR REAMER IRRIGATOR ASPIRATOR (RIA) 2 BROKE OFF INSIDE THE DRIVESHAFT. THE HEAD BECAME DISCONNECTED FROM THE SHAFT WHILE REAMING. THERE WAS NO SURGICAL DELAY. THE PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN DRIVE SHAFT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 13.0MM 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 12901825 ↗
• MalfunctionOct 1, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A TRAUMA PROCEDURE ON (B)(6), 2021, RIA 2 WAS USED TO TAKE BONE GRAFT FROM THE RIGHT FEMUR. DURING THE REAMER HEAD EXCHANGE, IT WAS NOTICED THAT THE TABS OF THE REAMER HEAD HAD BROKEN INSIDE THE IRRIGATION TUBE. AS NO OTHER DEVICE WAS AVAILABLE, THE SURGICAL TEAM HAD TO FISH OUT THE TABS FROM INSIDE THE TUBE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF FIFTEEN MINUTES. THIS REPORT IS FOR A 13.0MM 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 12565113 ↗
• InjuryMar 22, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, THE 13.0MM REAMER HEAD FOR THE RIA2 HEAD, SHAFT PORTION BROKE INSIDE A PATIENT'S FEMUR. THE PROCEDURE WAS FOR A COMPETITORS BILATERAL NAIL REMOVAL, AND RIA 2 GRAFTING WAS INCORPORATED. THE HEAD WAS OVER A BALL TIP AND CAME OUT, BUT FRAGMENTS WERE LEFT INSIDE THE FEMUR. X-RAYS WERE TAKEN AND THE FRAGMENTS REMAINED IN THE PATIENT. THERE WAS A TWO (2) TO THREE( 3) MINUTE OF SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT CONSEQUENCES ARE UNKNOWN. THIS REPORT INVOLVES ONE (1) 13.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11542330 ↗
• InjuryMar 2, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHILE REAMING, THE REAMER HEAD FOR RIA II BROKE. FOUR (4) METAL FLANGE PIECES WERE RETAINED IN THE MEDULLARY CANAL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WERE PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: REAMERS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1) THIS REPORT INVOLVES ONE (1) 13.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 11398298 ↗
• InjuryNov 16, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE 13MM REAMER HEAD GOT CAUGHT ON CEMENT IN THE TIBIA CANAL AND CAME OFF IN THE CANAL. THIS RESULTED IN PARTS OF THE REAMER HEAD BREAKING OFF IN THE CANAL. THE REAMER HEAD WAS SAFELY REMOVED. FRAGMENTS WERE GENERATED SMALL FRAGMENTS WERE LEFT IN THE CANAL. THERE WAS A SURGICAL DELAY OF ONE MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: RIA 2 REAMING KIT 520MM STERILE (PART# 03.404.001S, LOT# 56P1448, QUANTITY# 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 13.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 10846530 ↗
• InjuryOct 4, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A REVISION PROCEDURE DUE TO A TIBIAL NON-UNION ON (B)(6) 2020, WHILE APPLYING FORCE ON THE RIA 2 BONE HARVESTING KIT TO OBTAIN BONE GRAFT, THE PIECES THAT ATTACH THE REAMER HEAD TO THE SHAFT SPLINTERED OFF INSIDE THE CANAL OF THE TIBIA AND THE REAMER HEAD CAME OFF THE ASSEMBLY. THE PIECES OF METAL WERE NOT ABLE TO BE RETRIEVED. NOT MUCH BONE GRAFT WAS ACQUIRED SO A LARGER REAMER HEAD WAS USED. WHILE PULLING RIA2 ASSEMBLY OUT, THE REAMER HEAD GOT STUCK AND THE PLASTIC SHAFT SNAPPED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN RIA DRIVE SHAFT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 13.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 10624712 ↗
• MalfunctionSep 15, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, WHILE HARVESTING BONE GRAFT RIGHT FEMUR, THE REAMER IRRIGATOR ASPIRATOR (RIA) HAD TROUBLE MAKING THE TURN AROUND THE MEDIAL CORTEX, AND THE HEAD TINES SHEARED OFF. THE SURGEON RETRIEVED THE BROKEN PIECES, AND CONTINUED WITH A NEW KIT. FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10534889 ↗
• MalfunctionSep 15, 2020Break; Break

  IT WAS REPORTED THAT ON AUGUST 18, 2020, WHILE HARVESTING BONE GRAFT RIGHT FEMUR, THE REAMER IRRIGATOR ASPIRATOR (RIA) HAD TROUBLE MAKING THE TURN AROUND THE MEDIAL CORTEX, AND THE HEAD TINES SHEARED OFF. THE SURGEON RETRIEVED THE BROKEN PIECES AND CONTINUED WITH A NEW KIT. FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10534772 ↗
• MalfunctionMar 27, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING THE CASE THE RIA2 REAMER HEAD CAME DISCONNECTED FROM THE RIA2 TUBE ASSEMBLY AND REAMER SHAFT. THE GUIDEWIRE HAD TO BE PULLED OUT WHICH ALSO PULLED THE REAMER HEAD CAME OUT. THERE WAS DAMAGE TO THE REAMER HEAD SO IT COULD NOT BE REUSED. A BROKEN STRYKER GAMMA3 NAIL WAS REMOVED DURING THE CASE. A BROKEN SCREW THAT WAS PART OF THE OF THE BROKEN NAIL WAS LEFT BEHIND IN THE DISTAL FEMUR. THE SURGEON FELT HE COULD REAM AROUND BUT THE BROKEN SCREW HIT THE REAMER HEAD CAUSING THE DISCONNECTION AND DAMAGE THE REAMER HEAD. THERE WERE FRAGMENTS GENERATED FROM THE BROKEN DEVICE AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. NO BROKEN PRODUCT WAS LEFT BEHIND IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER RIA2 REAMER HEAD. THERE WAS A 8 MINUTES SURGICAL DELAY REPORTED. CONCOMITANT DEVICES REPORTED: RIA TUBE ASSEMBLY (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1), DRIVE SHAFT F/RIA 2 L520 (PART 03.404.035, LOT UNKNOWN, QUANTITY 1) GUIDE WIRE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1), STRYKER SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE 13.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9889842 ↗