R3 71366052Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 03596010580207), received between Mar 26, 2019 and Dec 12, 2025 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Break” (23 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THA SURGERY, ONE (1) R3 MIS X-BAR BROKE. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789223 ↗
• MalfunctionFeb 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE R3 MIS X-BAR SNAPPED. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 18630937 ↗
• MalfunctionMay 18, 2022Break; Break

  IT WAS REPORTED THAT, THAT THE METAL WELD OF AN R3 MIS X-BAR HAS BROKEN, DEVICE IS IN TWO PIECES RATHER THAN ONE UNIT. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14431917 ↗
• MalfunctionFeb 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BAR OF A R3 MINIMALLY INVASIVE SURGERY X-BAR FELL OUT OF TOP PORTION OF THE DEVICE, DUE TO BAD WELD. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13615289 ↗
• MalfunctionJan 27, 2022Break; Break

  IT WAS REPORTED THAT, AFTER A THR SURGERY, AN R3 MIS X-BAR BROKE. SINCE INCIDENT OCCURRED AFTER PROCEDURE, PATIENT WAS NOT LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13365210 ↗
• MalfunctionJan 6, 2022Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, A R3 MIS X-BAR BROKE WHILE OUTSIDE THE PATIENT. NO PIECES FELL INTO 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 13181113 ↗
• MalfunctionNov 22, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY SETUP, THE WELD ON A R3 MIS X-BAR BROKE OFF. SURGERY WAS PERFORMED WITH A BACKUP DEVICE, WITHOUT ANY DELAY. AS THIS PROBLEM OCCURRED BEFORE USE IN PATIENT, THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852558 ↗
• MalfunctionNov 12, 2021Break; Break

  IT WAS REPORTED THAT, DURING SET UP/INSPECTION SURGERY, THE PIECE THAT ATTACHES TO THE R3 MIS X-BAR BROKE OFF. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12805758 ↗
• MalfunctionNov 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, AN R3 MINIMALLY INVASIVE SURGERY X-BAR BROKE, NO PIECES FELL INSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787906 ↗
• MalfunctionOct 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING SET UP/INSPECTION FOR A THR PROCEDURE, THE CLIP OF A R3 MIS X-BAR BROKE OFF. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, THE PROCEDURE WAS FINISHED, BUT THE DEVICE WAS NOT USED. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657358 ↗
• MalfunctionSep 8, 2021Break; Break

  IT WAS REPORTED THAT ONE R3 MIS X-BAR BROKE DURING WASH. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12440865 ↗
• MalfunctionJul 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA, A R3 MIS X-BAR BROKE. NO PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS FINISHED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158911 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, A R3 MIS X-BAR BROKE OUTSIDE OF THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042929 ↗
• MalfunctionJun 14, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR, AN R3 MIS X-BAR BROKE OFF OUTSIDE THE PATIENT. NO DELAYS NOR INJURIES WERE REPORTED. PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11996096 ↗
• MalfunctionJun 14, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT AFTER A THR SURGERY, IT WAS NOTICED THAT THE R3 MIS X-BAR WAS BENT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11991474 ↗
• MalfunctionMay 28, 2021Break; Break

  IT WAS REPORTED THAT THE END OF THE R3 MIS X-BAR HAS FALLEN OFF. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904471 ↗
• MalfunctionMay 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A MIS X-BAR BROKE. DEVICE OUTSIDE 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 11898141 ↗
• MalfunctionApr 26, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION, IT WAS FOUND THAT THE R3 MIS X-BAR WAS BROKEN AT THE BASE INTO TWO SEPARATE PIECES. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729678 ↗
• MalfunctionMar 8, 2021Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY A PIECE OF THE MIS X-BAR BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431625 ↗
• MalfunctionMar 8, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, THE R3 MIS X-BAR WAS NOTICED TO BE BENT. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431079 ↗
• MalfunctionMar 8, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSPECTION PROCESS WAS FOUND THAT THE R3 MIS X-BAR IS BENT. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431075 ↗
• MalfunctionMar 8, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING INSPECTION IT WAS NOTICED THAT THE R3 MIS X-BAR IS BENT, THE R3 OFFSET IMPACTOR IS LOCKED UP AND WILL NO RELEASE. NO CASE INVOLVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431073 ↗
• MalfunctionMar 8, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE R3 MIS X-BAR ARE BENT. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431070 ↗
• MalfunctionMar 8, 2021Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT, DURING RECEIVING INSPECTION A R3 MIS X-BAR WAS FOUND BROKEN AT THE WELDING SEAM. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431003 ↗
• MalfunctionFeb 19, 2021Break; Break

  IT WAS REPORTED THAT, THE R3 MIS X-BAR'S WELD WAS CRACKED AT THE BASE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11347083 ↗

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