NA 352.250SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982194428), received between Jan 4, 2019 and Sep 14, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE TIP OF THE RIA DRIVE SHAFT BROKE INSIDE THE 12.0MM REAMER HEAD. THE BROKE SHAFT WAS REMOVED AND ALL FRAGMENTS WERE EASILY RETRIEVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER RIA SHAFT FROM THE SET WITH ANOTHER REAMER HEAD. THERE WAS A SURGICAL DELAY OF APPROXIMATELY TWO (2) MINUTES WHILE CHANGING REAMER SHAFTS. THIS REPORT IS FOR ONE (1) 12.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468280 ↗
• MalfunctionJan 30, 2019Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2019, THE REAMER/IRRIGATOR/ASPIRATOR (RIA) RIGHT SHAFT BROKE WHILE REAMING. THE DRIVE SHAFT ENDED UP GRINDING AGAINST THE FLANGES OF THE REAMER HEAD, CAUSING THE TIP OF THE SHAFT AND THE FLANGES OF THE REAMER HEAD TO BREAK. NO REVISION PROCEDURE IS NEEDED. PROCEDURE OUTCOME WAS NOT IMPACTED. PATIENT WAS NOT HARMED. THIS REPORT IS FOR A 12.0MM REAMER HEAD. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8289696 ↗
• MalfunctionJan 4, 2019Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE REAMER HEAD AND THE TIP OF A DRIVE SHAFT MINIMUM REAMER/IRRIGATOR/ASPIRATOR (RIA) BROKE DURING REAMING. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. PROCEDURE WAS COMPLETED NORMALLY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 12.0MM REAMER HEAD. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8217837 ↗

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-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-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-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-0587-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.032S
• 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-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-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
• 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-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-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-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-0581-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.026S
• Z-0580-2021 · Nov 19, 2020 · Terminated
  DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.025S
• 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

…and 4 more.