NA 71362750Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010456885), received between Jul 25, 2020 and Dec 27, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K123598); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TWO PRONGS CONNECTING ONE (1) REAMER DOME 50MM TO THE HANDLE BROKE OFF, LEAVING NO CROSS-SECTION. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS A SURGICAL DELAYED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21031358 ↗
• MalfunctionSep 20, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHEN USING A REAMER DOME 50MM IT BROKE, THE BROKEN PIECE WAS REMOVED WITH A HOOK. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267583 ↗
• MalfunctionOct 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, A REAMER DOME 50MM BROKE FROM ITS SUPPORT STRUTS, AS IT WAS BEING WITHDRAWN FROM THE ACETABULUM. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO X-RAYS OR REPORTS ARE AVAILABLE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17954475 ↗
• MalfunctionAug 10, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, THE ATTACHMENT BAR IN ONE (1) REAMER DOME 50MM SNAPPED DURING ATTEMPTED REAMING. ALL PARTS RETRIEVED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17502859 ↗
• MalfunctionJul 25, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY A R3 50MM REAMER DOME BROKE OUTSIDE OF THE PATIENT AFTER BEING USED. A S&N BACK UP WAS AVAILABLE. THE CASE WAS NOT DELAYED AND THERE WAS NOT AN ADVERSE EVENT WITH REGARDS TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10324347 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116