Anthology 71365703Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 03596010553393), received between Aug 3, 2020 and Aug 13, 2025 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (11 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, IT WAS NOTICED THAT ONE (1) OFFSET BROACH HANDLE WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 22801406 ↗
• MalfunctionJun 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THAT DURING A THR. THE OFFSET BROACH HANDLE POPS OFF THE BROACH WHEN TRYING TO EXTRACT THE BROACH FROM THE FEMUR. 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 17138229 ↗
• MalfunctionDec 16, 2021Break; Break

  IT WAS REPORTED THAT DURING THR THE OFFSET BROACH HANDLE BROKE AND DID NOT HOLD BROACH. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT. IS IT UNKNOWN IF THERE WAS A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019672 ↗
• MalfunctionJun 29, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, SIX (6) OFFSET BROACH HANDLE DON'T CLAMP DOWN PROPERLY. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12082357 ↗
• MalfunctionJun 29, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, SIX (6) OFFSET BROACH HANDLE DON'T CLAMP DOWN PROPERLY. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12082356 ↗
• MalfunctionJun 29, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, SIX (6) OFFSET BROACH HANDLE DON'T CLAMP DOWN PROPERLY. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12082353 ↗
• MalfunctionJun 29, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, SIX (6) OFFSET BROACH HANDLE DON'T CLAMP DOWN PROPERLY. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12082352 ↗
• MalfunctionJun 29, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, SIX (6) OFFSET BROACH HANDLE DON'T CLAMP DOWN PROPERLY. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12082350 ↗
• MalfunctionJun 29, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, SIX (6) OFFSET BROACH HANDLE DON'T CLAMP DOWN PROPERLY. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12082349 ↗
• MalfunctionMay 20, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING SURGERY, A OFFSET BROACH HANDLE WAS TOO LOOSE ON THE BROACH AND DID NOT STAY LOCKED TO TAKE BROACH OUT OF THE FEMUR. DEVICE 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 11860116 ↗
• MalfunctionMay 10, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A SET UP OR INSPECTION BEFORE A THR, WAS NOTICED THAT AN OFFSET BROACH HANDLE DID NOT STAY LOCKED ON BROACH. 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 11803282 ↗
• MalfunctionApr 6, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE BROACH HANDLE DISASSOCIATES FROM BROACH TOO EASILY. THIS WAS NOTICED DURING SERVICE/PM. NO CASE OR PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624880 ↗
• MalfunctionApr 6, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING INSPECTION IT WAS NOTICED THAT THE BROACH HANDLE DISASSOCIATES FROM BROACH TOO EASILY. NO CASE INVOLVED THEREFORE NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624876 ↗
• InjuryMar 8, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING TOTAL HIP REPLACEMENT INSTRUMENT OUTSIDE THE PATIENT, THE OFFSET BROACH HANDLE WAS WOBBLY WHEN CLAMPED. NO DELAY OR INJURY REPORTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431087 ↗
• MalfunctionMar 5, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING SURGERY, THE OFFSET BROACH HANDLE DID NOT HOLD ONTO RASP WHEN HAMMERING THE RASP OUT OF THE CANAL. THE PROCEDURE CONTINUED USING A BACKUP DEVICE FROM SMITH AND NEPHEW, WITHOUT SURGICAL DELAY, AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11419339 ↗
• MalfunctionFeb 25, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A THR THE OFFSET BROACH HANDLE WAS NOT GRIPPING, COMING OFF THE BROACHES WHEN BEING IMPACTED, NOTHING FELL INSIDE THE PATIENT WOUND. INSTRUMENTS INSIDE PATIENT. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. SURGICAL DELAY OF LESS THAN OR EQUAL TO 30 MINUTES. 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 11382440 ↗
• MalfunctionJan 19, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, THE DURING SET UP OR INSPECTION IT WAS NOTICED THAT THE OFFSET BROACH HANDLE IS NOT LONGER GRIPPING THE BROACHES. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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 11195692 ↗
• MalfunctionDec 16, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THR PROCEDURE WHILE OUTSIDE, THE CLOSURE (LOCKING) MECHANISM ON THE OFFSET BROACH HANDLE DIDN¿T SECURE A BROACH RASP. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING AN SMITH&NEPHEW BACKUP DEVICE. NO INJURY TO PATIENT WAS REPORTED. 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 11016114 ↗
• MalfunctionOct 8, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE INSPECTION BEFORE A THR IS WAS NOTICED THAT THE OFFSET BROACH HANDLE IS NOT LOCKING CORRECTLY. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. NO SURGICAL DELAY.

  Patient problems: No Patient Involvement

  MAUDE report 10646842 ↗
• MalfunctionAug 3, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE OFFSET BROACH HANDLE LOOSENED AND WILL NOT HOLD BROACHES TIGHT ENOUGH WHEN BROACHING. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10358711 ↗
• MalfunctionAug 3, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE OFFSET BROACH HANDLE LOOSENED AND WILL NOT HOLD BROACHES TIGHT ENOUGH WHEN BROACHING. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10358693 ↗

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