NA 352.252SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982194466), received between May 22, 2018 and Oct 15, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionOct 15, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING THE EXCHANGE OF INTRAMEDULLARY NAIL AND IN BETWEEN NAILS USING THE SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA), THE MIDDLE RIA SHAFT, THE TIP OF IT WHERE THE RIA HEAD ENGAGES TO THE REST OF IT BECAME BENT AND FRAIL A LITTLE BIT THAT CAUSED THE RIA HEAD TO FALL OFF THE MIDDLE SHAFT IN THE MEDULLARY CANAL OF THE PATIENT RESULTING THE DEVICE BEING SEPARATED. THEY HAD AN RIA HEAD INSIDE THE PATIENT WITH NOTHING ATTACHED TO IT. AS PER THE TECHNIQUE, IT WAS ON THE BALL TIP GUIDEWIRE THAT IT GOES OVER SO THE SURGEON WAS ABLE TO GET IT OUT WITHOUT ANY NEGATIVE IMPACT. THERE WAS NO NEGATIVE EFFECT ON THE PATIENT. THERE WAS A 5 MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICES. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7967723 ↗
• MalfunctionMay 22, 2018Break; Break

  IT WAS REPORTED, WHILE THE SURGEON WAS USING THE REAMER IRRIGATOR ASPIRATOR (RIA), THREE (3) RIA HEADS AND THE SHAFT OF THE DRIVE BROKE. ON (B)(6) 2018 A PATIENT, IMPLANTED WITH A COMPETITOR¿S DEVICE, WAS UNDERGOING A REVISION SURGERY DUE TO A NONUNION OF A PROXIMAL HUMERUS FRACTURE. WHILE THE SURGEON WAS HARVESTING BONE GRAFT FROM THE FEMUR, THREE (3) RIA HEADS BROKE- 15MM, 13MM, AND 12MM. IT WAS ALSO REPORTED THE SHAFT OF THE DRIVER BROKE. THE SURGERY WAS DELAYED FOR APPROXIMATELY TWENTY (20) MINUTES. NO FRAGMENTS WERE GENERATED AND NOTHING FELL INTO THE PATIENT WHEN THE BREAKAGE OCCURRED. PRODUCTS WILL NOT BE RETURNING. PATIENT STATUS WAS REPORTED AS STABLE. NO ADDITIONAL INFORMATION TO REPORT. THIS COMPLAINT INVOLVED FOUR (4) DEVICES ONLY. THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7535934 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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

…and 4 more.