NA 71935642Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556717424), received between Nov 4, 2020 and Jan 11, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 11, 2022Break; Break

  IT WAS REPORTED THAT A DOUBLE OFFSET BROACH HANDLE RIGHT IS BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED RELATIVE TO SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13226048 ↗
• MalfunctionAug 17, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT DURING A THR SURGERY, ONE DOUBLE OFFSET BROACH HANDLE RIGHT WAS TOUGH TO OPEN WHILE THE BROACH WAS LOADED. SURGERY WAS RESUMED WITH A SMITH AND NEPHEW BACKUP DEVICE, NO DELAY WAS REPORTED. THEREFORE, NO PATIENT INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12332823 ↗
• MalfunctionMay 31, 2021Physical Resistance/Sticking; Incomplete or Inadequate Connection; Physical Resistance/Sticking; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A THR, IT WAS NOTICED THAT WHEN TWO DOUBLE OFFSET BROACH HANDLES WERE TO TRY TO LOCK THE HANDLE DOWN ONTO THE BROACH, THE HANDLE WOULD GET STUCK AND BE VERY DIFFICULT TO LOCK DOWN AS WELL AS TO OPEN UP. NO PATIENT INJURY WAS REPORTED. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11909292 ↗
• MalfunctionMay 31, 2021Physical Resistance/Sticking; Incomplete or Inadequate Connection; Physical Resistance/Sticking; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A THR, IT WAS NOTICED THAT WHEN TWO DOUBLE OFFSET BROACH HANDLES WERE TO TRY TO LOCK THE HANDLE DOWN ONTO THE BROACH, THE HANDLE WOULD GET STUCK AND BE VERY DIFFICULT TO LOCK DOWN AS WELL AS TO OPEN UP. NO PATIENT INJURY WAS REPORTED. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11909285 ↗
• MalfunctionApr 20, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THA PROCEDURE A DOUBLE OFFSET BROACH HANDLE WAS FOUND BROKEN AND NEEDS TO BE REPLACED. THIS HAPPENED DURING PROCEDURE, COMPLETED WITH THE SAME DEVICE AND THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693238 ↗
• MalfunctionNov 4, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A THR THE DOUBLE OFFSET BROACH HANDLE RIGHT IS NOT LOCKING ON TO BROACH VERY WELL. INSTRUMENTS OUTSIDE PATIENT. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. NO DELAY OR INJURY REPORTED DUE THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10786280 ↗
• MalfunctionNov 4, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING A THR, THE DOUBLE OFFSET BROACH HANDLE RIGHT IS NOT LOCKING ON TO BROACH VERY WELL. INSTRUMENTS OUTSIDE PATIENT. PROCEDURE FINISHED WITH SAME DEVICE. NO DELAY OR INJURY REPORTED DUE THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10786110 ↗

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