NA 352.253SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982194480), received between Nov 30, 2017 and Apr 21, 2022 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

19 other recalls cover devices cleared under the same FDA submission (K013527, K042899, K111437); they may or may not involve this specific model.

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.

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.

• MalfunctionApr 21, 2022Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER THAT DURING AN UNKNOWN SURGERY OF THE FEMUR ON (B)(6) 2022, IT WAS OBSERVED THAT THE REAMER HEAD AND DRIVE SHAFT DEVICES BROKE DURING REAMING OF THE PATIENT'S FEMUR. ANOTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE PATIENT WAS REPORTED TO BE FINE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 13.5 REAMER HD-S REAMER/IRRIGATOR/ASPIRATOR DEVICE. THIS COMPLAINT INVOLVES 2 DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14167686 ↗
• InjuryDec 1, 2020Break; Entrapment of Device; Break; Entrapment of Device

  THERE WERE SOME VERY SMALL METAL FRAGMENTS IN THE RIA BONE GRAFT THAT WERE RE-INSERTED BACK INTO THE DEFECT IN ORDER TO STIMULATE HEALING.

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

  MAUDE report 10928088 ↗
• InjuryDec 1, 2020Break; Entrapment of Device; Break; Entrapment of Device

  THERE WERE SOME VERY SMALL METAL FRAGMENTS IN THE RIA BONE GRAFT THAT WERE RE-INSERTED BACK INTO THE DEFECT IN ORDER TO STIMULATE HEALING.

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

  MAUDE report 10928078 ↗
• MalfunctionFeb 28, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A DISTAL FEMUR REVISION, THE SCRUB TECHNICIAN WAS SETTING UP AND ASSEMBLE THE REAMER/IRRIGATOR/ASPIRATOR (RIA) ONTO THE RIA TUBE ASSEMBLY. TWO LEGS OF THE REAMER HEAD BROKE OFF. A SECOND REAMER HEAD WAS OPENED TO USE FOR THE CASE. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A REAMER HEAD. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8378009 ↗
• MalfunctionNov 30, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED DURING A LEFT FEMUR REAMING IN TREATMENT OF A DISTAL TIBIA NON-UNION, THE RIA SYSTEM WAS UTILIZED FOR BONE GRAFTING MATERIAL AND THE DRILL HEADS WOULD NOT ADVANCE PROPERLY. THE SURGEON USED EXTREME FORCE IN REAMING AND FELT THE HEAD WAS DULL SO ANOTHER HEAD WAS UTILIZED. THE SAME ISSUE OCCURRED AND IT WAS DIFFICULT TO ADVANCE THROUGH THE BONE. THE SURGEON SWITCHED OUT THE SHAFT AND THEN SWITCHED BACK TO THE ORIGINAL SHAFT AND HEAD TO COMPLETE THE PROCEDURE. A 10-15 MINUTE SURGICAL DELAY WAS NOTED DUE TO THE DIFFICULTY IN REAMING. NO DEVICES BROKE. THERE WAS NO INFORMATION ON THE INITIAL FRACTURE OR ANY HARDWARE INITIALLY IMPLANTED. CONCOMITANT DEVICES. REAMER SHAFT (PART# 314.743, LOT# UNKNOWN, QTY 2). THIS IS REPORT 2 OF 2 FOR (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7072666 ↗
• MalfunctionNov 30, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED DURING A LEFT FEMUR REAMING IN TREATMENT OF A DISTAL TIBIA NON-UNION, THE RIA SYSTEM WAS UTILIZED FOR BONE GRAFTING MATERIAL AND THE DRILL HEADS WOULD NOT ADVANCE PROPERLY. THE SURGEON USED EXTREME FORCE IN REAMING AND FELT THE HEAD WAS DULL SO ANOTHER HEAD WAS UTILIZED. THE SAME ISSUE OCCURRED AND IT WAS DIFFICULT TO ADVANCE THROUGH THE BONE. THE SURGEON SWITCHED OUT THE SHAFT AND THEN SWITCHED BACK TO THE ORIGINAL SHAFT AND HEAD TO COMPLETE THE PROCEDURE. A 10-15 MINUTE SURGICAL DELAY WAS NOTED DUE TO THE DIFFICULTY IN REAMING. NO DEVICES BROKE. THERE WAS NO INFORMATION ON THE INITIAL FRACTURE OR ANY HARDWARE INITIALLY IMPLANTED. CONCOMITANT DEVICES. REAMER SHAFT (PART# 314.743, LOT# UNKNOWN, QTY 2). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7072460 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013527, K042899, K111437. One submission often covers many models, so check the product and lot details in each record.

• Z-1237-2024 · Jan 24, 2024 · Open, Classified
  RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effective
• Z-0579-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.024S
• Z-0574-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S
• Z-0578-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.023S
• Z-0585-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.030S
• Z-0583-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S
• Z-0573-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S
• Z-0577-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.022S
• Z-0586-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.031S
• Z-0572-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.017S
• Z-0575-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S
• Z-0582-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.027S
• Z-0576-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.021S
• Z-0584-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S
• Z-0571-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S

…and 4 more.