R3 71366021Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03596010580184), received between Apr 24, 2019 and Mar 27, 2024 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE TIP OF ONE (1) R3 LINER REMOVAL TOOL BROKE OFF DURING IMPACTION. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988324 ↗
• MalfunctionFeb 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THR SURGERY, TIP OF THE R3 LINER REMOVAL TOOL WAS CHIPPED. THE ISSUE WAS NOTICED BEFORE THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A COMPETITOR DEVICE. SURGERY WAS LESS THAN OR EQUAL TO 30MINS DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16301824 ↗
• MalfunctionApr 20, 2022Break; Break

  IT WAS REPORTED THAT, A R3 LINER REMOVAL TOOL WAS FOUND TO HAVE A BROKEN TIP DURING INSPECTION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14154419 ↗
• MalfunctionApr 7, 2022Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT THE TIP OF THE R3 LINER REMOVAL TOOL WAS CHIPPED AND RUSTING. AS THIS WAS NOTICE IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14042472 ↗
• MalfunctionAug 18, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, A R3 LINER REMOVAL TOOL WAS BROKEN. SURGERY WAS RESUMED, WITHOUT ANY DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED AND WHEN OCCURRED RELATED TO SURGERY; HOWEVER, PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12336490 ↗
• MalfunctionAug 10, 2021Crack; Crack

  IT WAS REPORTED THAT A R3 LINER REMOVAL TOOL IS CHIPPED. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304063 ↗
• MalfunctionMay 26, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING A THR SURGERY, A R3 LINER REMOVAL TOOL DID NOT FUNCTION PROPERLY AS THE TIP BROKE OFF. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11887632 ↗
• InjuryApr 27, 2021Break; Break

  IT WAS REPORTED THAT DURING A THR, A R3 LINER REMOVAL TOOL BROKE REMOVING A LINER INSIDE THE PATIENT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. THE PATIENT WAS NOT INJURED BEYOND THE DESCRIBED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11730140 ↗
• MalfunctionOct 22, 2020Corroded; Corroded

  IT WAS REPORTED THAT DURING CLEANING THE R3 LINER REMOVAL TOOL THAT IS A NEW INSTRUMENT THAT HAS NEVER BEEN USED AND PASSED THROUGH THE STERILIZER ONCE, IT SHOWED RUST. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10720852 ↗
• MalfunctionOct 22, 2020Corroded; Corroded

  IT WAS REPORTED THAT DURING CLEANING THE R3 LINER REMOVAL TOOL THAT IS A NEW INSTRUMENT THAT HAS NEVER BEEN USED AND PASSED THROUGH THE STERILIZER ONCE, IT SHOWED RUST. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10720824 ↗
• MalfunctionJun 20, 2019Break; Break

  IT WAS REPORTED THAT DURING A THR, DEVICE TIP BECAME DAMAGED WHILE REMOVING LINER. NO DELAY. NO CONFIRMATION OF BACKUP HAS BEEN RECEIVED. NO IMPACT OR INJURY TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8720145 ↗
• MalfunctionApr 24, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE TIP OF THE DEVICE BROKE. PIECES WERE RECOVERED. BACK UP DEVICE AVAILABLE AND USED. NO INJURIES REPORTED. NO MORE INFORMATION PROVIDED YET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546918 ↗

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