NA 352.251SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982194442), received between Nov 19, 2018 and Mar 9, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, THE RIA REAMING ROD AND REAMING DRIVE SHAFT BROKE. FRAGMENTS WERE NOT GENERATED OR LEFT IN THE PATIENT. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 12.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11445723 ↗
• InjuryNov 19, 2018Break; Break

  11/21/2018: UPDATE EVENT DESCRIPTION TO CAPTURE 2 DEVICES INVOLVEMENT: IT WAS REPORTED THAT ON NOVEMBER 01, 2018, THE SURGEON WAS USING THE REAMER/IRRIGATOR/ASPIRATOR (RIA) AND WHILE REAMING THE NONUNION OF THE TIBIA, THE REAMER HEAD BROKE IN THE CANAL ALONG WITH A PIECE OF THE PLASTIC REAMER SHAFT. THE SURGEON WAS ABLE TO REMOVE THE REAMER HEAD AND THE BROKEN PIECE OF PLASTIC FROM THE CANAL. AN EXTRA INCISION WAS MADE TO REMOVE THE PIECE OF PLASTIC AT THE ENTRY POINT FOR THE TIBIAL NAIL. THE REAMER HEAD WAS REMOVED WITH REAMING ROD AND THE PIECE OF PLASTIC WAS REMOVED THROUGH A SEPARATE INCISION BELOW THE PATELLA. THERE WAS A FIVE-MINUTE SURGICAL DELAY REPORTED. THE PROCEDURE WAS COMPLETED AS PLANNED. PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8086646 ↗

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-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
• 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-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-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-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-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-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-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-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-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-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-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

…and 4 more.