NA 71364007Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 03596010199232), received between Feb 21, 2019 and Feb 23, 2026 — classified as 2 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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. 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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT BEFORE A THR, THE BROACH HANDLE BROKE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413121 ↗
• MalfunctionOct 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THR SURGERY, IN THE BROACH HANDLE, RIVET OR SET PIN COMING OUT DURING BROACHING PROCESS. 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 20435529 ↗
• MalfunctionMay 11, 2022Break; Break

  IT WAS REPORTED THAT A BROACH HANDLE WAS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14352612 ↗
• MalfunctionNov 17, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT, DURING A THR SURGERY, A BROACH HANDLE DOES NOT HOLD THE GRIP. SURGERY WAS COMPLETED WITH A BACKUP DEVICE, AFTER A DELAY GREATER THAN 30 MINS. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12828216 ↗
• MalfunctionOct 6, 2021Break; Break

  IT WAS REPORTED THAT A BROACH HANDLE IS BROKEN. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12584017 ↗
• MalfunctionOct 6, 2021Crack; Crack

  IT WAS REPORTED THAT, THE TIP OF A FEMORAL HEAD/NECK IMPACTOR IS CRACKED. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12584004 ↗
• MalfunctionJun 22, 2021Corroded; Corroded

  IT WAS REPORTED THAT TWO BROACH HANDLE WERE RUSTING. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038838 ↗
• MalfunctionJun 22, 2021Corroded; Corroded

  IT WAS REPORTED THAT TWO BROACH HANDLE WERE RUSTING. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038832 ↗
• MalfunctionMay 18, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE BROACH HANDLE NO LONGER CONNECTS. NO CASE INVOLVED; THEREFORE, NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842459 ↗
• MalfunctionMay 14, 2021Fitting Problem; Incomplete or Inadequate Connection; Fitting Problem; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING THR SURGERY, THE BROACH HANDLE DID NOT GRIPPED ON TO INSTRUMENTS. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11828823 ↗
• MalfunctionMay 14, 2021Naturally Worn; Incomplete or Inadequate Connection; Naturally Worn; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE BROACH HANDLE WAS WORN OUT AND WILL NOT GRASP THE BROACH TIGHT ENOUGH. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826303 ↗
• MalfunctionMay 14, 2021Naturally Worn; Incomplete or Inadequate Connection; Naturally Worn; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE BROACH HANDLE WAS WORN OUT AND WILL NOT GRASP THE BROACH TIGHT ENOUGH. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826207 ↗
• MalfunctionMay 14, 2021Naturally Worn; Incomplete or Inadequate Connection; Naturally Worn; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE BROACH HANDLE WAS WORN OUT AND WILL NOT GRASP THE BROACH TIGHT ENOUGH. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826164 ↗
• MalfunctionApr 23, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT AFTER THR SURGERY THE SYNERGY BROACH HANDLES IS LOOSE THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11712623 ↗
• MalfunctionApr 22, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT AFTER THR SURGERY THE SYNERGY BROACH HANDLES IS LOOSE THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11711324 ↗
• MalfunctionFeb 14, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING INSPECTION, HANDLE WAS NOTICED TO BE LOOSE WHEN ATTACHED TO BROACH. A BACKUP DEVICE FROM SMITH AND NEPHEW WAS AVAILABLE AND NO DELAY OR INJURY OCCURRED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326151 ↗
• MalfunctionFeb 14, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING INSPECTION, HANDLE WAS NOTICED TO BE LOOSE WHEN ATTACHED TO BROACH. A BACKUP DEVICE FROM SMITH AND NEPHEW WAS AVAILABLE AND NO DELAY OR INJURY OCCURRED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326149 ↗
• MalfunctionFeb 5, 2021Break; Break

  IT WAS REPORTED THAT, THE BROACH HANDLE WAS BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A 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 11284639 ↗
• MalfunctionFeb 5, 2021Break; Break

  IT WAS REPORTED THAT, THE BROACH HANDLE WAS BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A 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 11284638 ↗
• MalfunctionJan 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING SETUP IT WAS NOTICED THAT THE BROACH HANDLE'S LOCKING MECHANISM WAS BROKEN. 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 11195310 ↗
• MalfunctionJan 19, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING SETUP IT WAS NOTICED THAT THE LOCKING MECHANISM OF THE BROACH HANDLE NO LONGER HELD THE BROACH FIRMLY. 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 11195231 ↗
• MalfunctionJan 13, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING SURGERY THE BROACH HANDLE HAD A METAL PIN NEAR THE STRIKE SURFACE AND APPEARED LOOSE. SURGERY NOT DELAYED. CASE COMPLETED WITH SAME DEVICE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11159389 ↗
• MalfunctionJan 13, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING SURGERY BROACH HANDLE WAS FOUND TO BE LOOSE. SURGERY NOT DELAYED. CASE COMPLETED WITH SAME DEVICE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11159345 ↗
• MalfunctionDec 22, 2020Break; Break

  IT WAS REPORTED THAT DURING USE, OUTSIDE THE PATIENT, THE BROACH HANDLE BROKE, THE CLAMP WILL NO LONGER HOLD ONTO THE BROACHES. THE PROCEDURE FINISHED WITH THE SAME DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11055949 ↗
• MalfunctionDec 16, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT THE BROACH HANDLE ARE LOOSE WHEN ATTACHED TO THE BROACH. THERE WAS A DELAY LESS THAN OR EQUAL TO 30 MINUTES. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACKUP DEVICE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11023827 ↗

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