NA 352.260SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982194619), received between Nov 6, 2017 and Nov 6, 2017 — classified as 1 malfunction.

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

19 other recalls cover devices cleared under the same FDA submission (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2017Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INTRAMEDULLARY NAILING PROCEDURE ON (B)(6) 2017 TO TREAT A LEFT FEMUR FRACTURE. DURING THE SURGERY THE LOCKING CLIP ATTACHMENT DISENGAGED FROM BOTH THE REAMER IRRIGATOR ASPIRATOR (RIA) TUBE ASSEMBLY AND THE RIA DRIVE SHAFT AND FELL ON THE FLOOR. THE SURGEON WAS ONLY 2 OR 3 CENTIMETERS FROM THE EXITING THE CANAL; THEREFORE, THE SURGERY WAS COMPLETED WITHOUT USE OF THE DRILL. THERE WAS A ONE TO TWO MINUTE DELAY IN ORDER TO REAM ACROSS THE FRACTURE SLOWLY USING PROPER TECHNIQUE (WITHOUT USE OF THE DRILL). IN ADDITION, THE TIP OF THE DRIVE SHAFT BROKE OFF INSIDE THE RIA TUBE ASSEMBLY AND THE REAMER HEAD. ALL FRAGMENTS WERE REMOVED; NOTHING REMAINED IN THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH PATIENT OUTCOME AS EXPECTED. THIS COMPLAINT INVOLVES 1 DEVICE. CONCOMITANT DEVICES REPORTED: PART NUMBER 314.746S / UNKNOWN LOT NUMBER, QUANTITY X 1. PART NUMBER 352.250S / UNKNOWN LOT NUMBER, QUANTITY X 1. REAMER HEAD (UNKNOWN PART AND LOT NUMBERS) QUANTITY X 1. BATTERY REAMER DRILL (UNKNOWN PART AND LOT NUMBERS) QUANTITY X 1. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7003225 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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-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
• 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-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-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-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-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-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-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-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-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.