NA 03.404.023SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982274045), received between Jan 29, 2021 and Oct 24, 2025 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 18, 2026.

Recalls naming this device

1. Nov 19, 2020Class IITerminated

   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-0578-2021 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2025 DURING THE PROCEDURE, THE ITEM WAS MALFUNCTIONING. THERE WAS NO HARM FOR THE PATIENT, BUT A FRAGMENT WAS NOT ABLE TO TAKE OUT FROM THE PATIENT AS THE PART WAS BROKEN. A SECOND ITEM WAS IDENTIFIED TO BE BROKEN UPON DEVICE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381065 ↗
• MalfunctionSep 19, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2025 DURING THE PROCEDURE THE REAMER HEAD BROKE AND THE FRAGMENT WAS NOT ABLE TO BE RETRIEVED FROM THE PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 23098077 ↗
• MalfunctionAug 15, 2025Break; Break

  IT WAS REPORTED THAT THE ITEM BROKE DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22817539 ↗
• MalfunctionAug 14, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON JULY 7, 2025, THERE WAS AN ISSUE WITH A REAMER HEAD AND SURGICAL TEAM UNABLE TO RETRIEVE THE FRAGMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22806294 ↗
• MalfunctionJun 28, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING RIA2 GRAFT HARVEST PROCEDURE FOR LEFT FEMUR THE REAMER HEAD WAS BROKEN. THE REAMER BROKEN HEAD WAS REMOVED AND RESUMED GRAFT HARVEST WITH NEW REAMER HEAD. THERE WAS A SURGICAL DELAY OF 5 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS GENERATION OF FRAGMENTS WHICH WAS NOT REMOVED BY ADDITIONAL INTERVENTION. THE REAMER HEAD FRAGMENT REMAINED IN PATIENT. THERE WAS PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 13.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19639122 ↗
• MalfunctionDec 11, 2023Break; Break

  DEVICE REPORT FROM COSTA RICA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON 16-NOVEMBER-2023, WHILE REAMING THE MEDULLARY CANAL WITH THE PRODUCT IN QUESTION, THE SURGEON ENCOUNTERED RESISTANCE. THE SURGEON CONTINUED ON WITH THE PROCEDURE, WHICH CAUSED THE HEAD TO DROP METAL SHARDS INTO THE BONE AND THE HOSE TO BEND. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 13.5MM 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 18300481 ↗
• 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 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 13.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18039483 ↗
• 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 13.5MM 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 18039185 ↗
• InjuryJul 10, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, THE RIA 2 HEAD SHEARED OFF DURING A FEMORAL NON-UNION CASE. THE SURGERY WAS DELAYED BY THREE MINUTES, AND THE FRAGMENTS GENERATED WERE UNABLE TO BE REMOVED. THIS REPORT INVOLVES ONE 13.5MM REAMER HEAD FOR RIA 2 STERILE FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17286554 ↗
• MalfunctionFeb 22, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023 WHILE HARVESTING BONE GRAFT WITH THE RIA2, THE REAMER HEAD BROKE AND DETACHED FROM THE RIA2 TUBE ASSEMBLY. THERE WERE 80 MINS OF SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 13.5MM REAMER HEAD FOR RIA 2 STERILE THIS IS REPORT 1 OF 2 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417720 ↗
• InjuryJun 3, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED DURING SURGERY ON (B)(6) 2022, THE RIA REAMER HEAD BROKE INTRAOPERATIVELY. THERE WAS AN SURGICAL DELAY OF AN UNKNOWN AMOUNT OF TIME. FRAGMENTS REMAINED BEHIND IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A REAMER HEAD.

  Patient problems: Foreign Body In Patient

  MAUDE report 14596791 ↗
• InjuryAug 20, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING AN ANKLE FUSION PROCEDURE ON (B)(6) 2021, THE RIA 2 REAMER HEAD DETACHED OUT OF THE RIA SHAFT AT THE CANAL OF THE DISTAL TIBIA. PIECES WERE RETRIEVED WITH A BALL-TIP WIRE, EXCEPT FOR 3 PRONGS LEFT INSIDE THE MEDULLARY CANAL. PROCEDURE WAS COMPLETED WITH NO DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 13.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12349475 ↗
• InjuryJan 29, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON HAD SOME DIFFICULTY PUSHING THE REAMER HEAD FOR RIA2 SHAFT DOWN THE LEFT FEMORAL CANAL. THE REAMER TIP WAS GETTING HUNG UP ON THE MEDIAL CORTEX. TO OVERCOME THIS, SURGEON HIT THE BACK OF THE DRILL A COUPLE OF TIMES WITH A MALLET; SIMILAR BLOWS, AS ONE WOULD DO TO SEAT A NAIL A FEW MORE MILLIMETERS. THE SHAFT WAS ADVANCED USING THIS TECHNIQUE AND PROPER USE OF THE RIA2 WAS USED. WHEN THE SURGEON BACKED OUT THE RIA2 FROM THE CANAL, THERE APPEARED TO BE METAL SHARDS LEFT IN THE CANAL. THE REAMER HEAD WAS INSPECTED, AND IT WAS DISCOVERED THAT THE SHAFT PORTION (OPPOSITE END OF CUTTING FLUTES) HAD BEEN SHEARED OFF. THE SURGEON REAMED ONE MORE TIME USING RIA2 WITH A 14MM TO GAIN MORE GRAFT AND HOPEFULLY PUSH OR REMOVE THOSE METAL PIECES. HE WAS ABLE TO CAPTURE ONE SHARD AND LEFT THE REMAINING ONES IN THE PATIENT¿S FEMUR. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. CONCOMITANT DEVICE REPORTED: DRILL (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1); MALLET (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 13.5MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11251275 ↗