NA 352.255SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982194527), received between Nov 25, 2021 and Nov 25, 2021 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR ANKLE RECONSTRUCTION SURGERY. DURING THE SURGERY, IT WAS FOUND THAT THE REAMER HEAD HAD SHEERED OFF AT THE CONNECTION TO THE DRIVE SHAFT AND RIA TUBE ASSEMBLY. THE REAMER HEAD WAS RETAINED INSIDE THE FEMUR. THE PLASTIC TUBING ON THE RIA TUBE ASSEMBLY WAS ALSO FOUND TO BE DISTORTED AND RUPTURED. THE RIA DRIVE SHAFT CANNOT BE DISCONNECTED FROM THE TUBE ASSEMBLY. ALL FRAGMENTS THAT THE SURGEON WAS ABLE TO EXTRACT FROM THE FEMUR WERE EXTRACTED. THERE ARE UNKNOWN VISIBLE ARTIFACTS ON THE X-RAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 15-MINUTES DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED. UNKNOWN ROD (PART# UNKNOWN, LOT# UNKNOWN, QTY 2); UNKNOWN SET SCREW (PART# UNKNOWN, LOT# UNKNOWN, QTY 6). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 14.5 REAMR HD-S REAMR/IRRIGATR/ASPIRATOR. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12876126 ↗

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

…and 4 more.