NA 71364012Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 03596010199287), received between Apr 3, 2020 and Aug 25, 2025 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, WHILE TAKING THE BROACH OUT OF THE FEMUR, THE THREAD TIP ON ONE (1) ANTEVERSION HANDLE BROKE OFF. NO BROKEN PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883375 ↗
• MalfunctionSep 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, AN ANTEVERSION HANDLE BROKE OFF INSIDE THE DBL OFFSET BROACH HDLE RT IMPACTOR. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785491 ↗
• MalfunctionOct 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY A ANTEVERSION HANDLE BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED; HOWEVER, THERE WAS A DELAY GREATER THAN 30 MIN. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15535467 ↗
• MalfunctionJun 8, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE THREADS THAT CONNECT INTO THE ANTEVERSION HANDLE SHEARED OFF. ALL PIECES WERE CAPTURED. 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 14640325 ↗
• MalfunctionJun 8, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE THREADS OF AN ANTEVERSION HANDLE BROKE OFF. NO PIECE FELL INSIDE THE PATIENT. SURGERY WAS FINISHED WITHOUT ANY DELAY, WITH A THE SAME DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14630135 ↗
• MalfunctionMay 6, 2022Break; Break

  IT WAS REPORTED THAT, AN ANTEVERSION HANDLE IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14310793 ↗
• InjuryApr 25, 2022Break; Break

  IT WAS REPORTED THAT, DURING THR, THE ANTEVERSION HANDLE BROKE INSIDE OF THE DBL OFFSET BROACH HDLE LT. PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192100 ↗
• InjuryApr 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHILE BROACHING WITH MALLET, THE ANTEVERSION HANDLE BROKE OFF AND STUCK INSIDE THE DBL OFFSET BROACH HDLE LT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192058 ↗
• MalfunctionMar 8, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHEN SURGEON WAS BROACHING THE CANAL WITH THE OFF SET IMPACTOR, THE ANTEVERSION HANDLE SNAPPED OFF ON THE BROACH AND PART OF THE HANDLE LEFT ON THE DBL OFFSET BROACH HDLE RT. SURGERY WAS FINISHED WITHOUT ANY DELAY, WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690502 ↗
• MalfunctionDec 30, 2021Break; Break

  IT WAS REPORTED THAT THE TIP OF A ANTEVERSION HANDLE WAS NOTICED TO BE BROKEN. SINCE THIS HAPPENED DURING A FIELD INSPECTION, NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119313 ↗
• MalfunctionOct 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE ANTEVERSION HANDLE ROD BROKE OFF IN A DBL OFFSET BROACH HDLE RT. INCIDENT OCCURED WHILE INSTRUMENTS WERE OUTSIDE THE PATIENT. SURGERY WAS COMPLETED, WITHOUT ANY DELAY USING A SN BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12595097 ↗
• MalfunctionSep 15, 2021Break; Break

  IT WAS REPORTED THAT, THE THREADED PART OF AN ANTEVERSION HANDLE IS BROKEN OFF. AS THIS WAS NOTICED AFTER CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12476013 ↗
• MalfunctionApr 28, 2021Corroded; Corroded

  IT WAS REPORTED THAT THE ANTEVERSION HANDLE HAD RUST ON IT. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742464 ↗
• MalfunctionJan 28, 2021Break; Break

  IT WAS REPORTED THAT IN A TOTAL HIP REPLACEMENT THE ANTEVERSION HANDLE WAS NOTICED BROKE. IT IS UNKNOWN WHEN THE EVENT OCCURRED. SMITH AND NEPHEW BACKUP DEVICE WAS AVAILABLE. NO INJURY OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11248234 ↗
• MalfunctionDec 11, 2020Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY THE ANTEVERSION HANDLE BROKE WHILE SCREWED INTO THE BROACH HANDLE. NO PIECES FELL INTO THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, BY USING A SMITH AND NEPHEW BACK UP DEVICE. 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 10991609 ↗
• MalfunctionNov 11, 2020Break; Break

  IT WAS REPORTED THAT THE HANDLE OF THE DEVICE BROKE. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10826444 ↗
• MalfunctionNov 4, 2020Break; Break

  IT WAS REPORTED THAT THE ANTEVERSION HANDLE IS BROKEN. IT DID NOT OCCUR DURING PROCEDURE. THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10785967 ↗
• MalfunctionSep 1, 2020Break; Break

  IT WAS REPORTED THAT BOTH OF THESE HANDLES BROKE WHEN IMPACTED. THE SURGEON MISSED THE IMPACTING PLATE AND BROKE. NOTHING FELL INTO PATIENT, NO HARM TO PATIENT, NO DELAY TO PROCEDURE, S&N BACKUP USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10480404 ↗
• MalfunctionSep 1, 2020Break; Break

  IT WAS REPORTED THAT BOTH OF THESE HANDLES BROKE WHEN IMPACTED. THE SURGEON MISSED THE IMPACTING PLATE AND BROKE. NOTHING FELL INTO PATIENT, NO HARM TO PATIENT, NO DELAY TO PROCEDURE, S&N BACKUP USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10479839 ↗
• MalfunctionApr 3, 2020Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE THE THREADED END OF THE ANTEVERSION HANDLE BROKE OFF. ALL PIECES WERE RECOVERED FROM THE PATIENT. A BACKUP DEVICE WAS REPORTED NOT AVAILABLE. THERE WAS NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9925123 ↗

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