NA 71360089Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 03596010610355), received between Mar 19, 2018 and Jan 29, 2026 — classified as 2 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Break” (27 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 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) DBL OFFSET BROACH HDLE LT BROKE. THE PROCEDURE WAS RESUMED, 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 24209738 ↗
• MalfunctionOct 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, ONE (1) DBL OFFSET BROACH HDLE LT DEVICES SNAPPED OFF INSIDE BROACH. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15685631 ↗
• MalfunctionOct 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE DBL OFFSET BROACH HDLE LT SNAPPED OFF INSIDE BROACH. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656083 ↗
• MalfunctionOct 4, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT, DURING A THA SURGERY A DBL OFFSET BROACH HDLE LT IS LOOSE. 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 15535460 ↗
• MalfunctionOct 4, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT, DURING A THA SURGERY A DBL OFFSET BROACH HDLE LT IS LOOSE. 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 15535458 ↗
• MalfunctionSep 30, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT, DURING A THA SURGERY A DBL OFFSET BROACH HDLE LT IS LOOSE. 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 15519073 ↗
• MalfunctionApr 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE SURGEON WAS TAKING OUT A BROACH WITH THE DBL OFFSET BROACH HDLE LT AND THE BACK OF THE HANDLE CAME OFF. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141864 ↗
• MalfunctionOct 15, 2021Break; Break

  IT WAS REPORTED THAT, A DBL OFFSET BROACH HDLE LT WAS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643452 ↗
• MalfunctionJun 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, A PIECE OF A DBL OFFSET BROACH HDLE LEFT BROKE OFF. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACKUP DEVICE INSTEAD, AFTER A NON SIGNIFICANT DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12043003 ↗
• MalfunctionJun 2, 2021Break; Break

  IT WAS REPORTED THAT THE DBL OFFSET BROACH HDLE LT LOCKING MECHANISM WAS BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918383 ↗
• MalfunctionMay 20, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE DBL OFFSET BROACH HANDLE LT WAS NO LONGER HOLDING BROCHES FIRMLY AND WAS SLIPPING. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. NO PATIENT INJURIES AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860110 ↗
• MalfunctionMay 19, 2021Connection Problem; Naturally Worn; Connection Problem; Naturally Worn

  IT WAS REPORTED THAT A DBL OFFSET BROACH HDLE LT WAS WORN AND CAN'T LOCK THE BROACH ON SECURELY. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848998 ↗
• MalfunctionMay 19, 2021Connection Problem; Naturally Worn; Connection Problem; Naturally Worn

  IT WAS REPORTED THAT, THREE (3) DBL OFFSET BROACH HDLE LT ARE WORN AND CAN'T LOCK THE BROACH ON SECURELY. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848929 ↗
• MalfunctionMay 19, 2021Connection Problem; Naturally Worn; Connection Problem; Naturally Worn

  IT WAS REPORTED THAT, THREE (3) DBL OFFSET BROACH HDLE LT ARE WORN AND CAN'T LOCK THE BROACH ON SECURELY. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848893 ↗
• MalfunctionMay 13, 2021Break; Break

  IT WAS REPORTED THAT, A DBL OFFSET BROACH HDLE LT WAS UNABLE TO BE USED BECAUSE THE SPRING BROKE. NO CASE INVOLVED; THEREFORE, NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820480 ↗
• MalfunctionMay 11, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING THR, WHEN STRUCK WITH A MALLET, THE DBL OFFSET BROACH HDLE LT RELEASED FROM THE BROACH. IT WAS USE A SMITH AND NEPHEW BACK UP DEVICE TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810104 ↗
• MalfunctionMay 11, 2021Misconnection; Misconnection

  IT WAS REPORTED THAT, DURING A THR A DBL OFFSET BROACH HDLE LT DID NOT PROPERLY GRIPPING BROACHES. INSTRUMENT 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 11807830 ↗
• MalfunctionMay 11, 2021Misconnection; Misconnection

  IT WAS REPORTED THAT, DURING A THR A DBL OFFSET BROACH HDLE LT DID NOT PROPERLY GRIPPING BROACHES. INSTRUMENT 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 11807148 ↗
• MalfunctionApr 23, 2021Break; Break

  IT WAS REPORTED THAT, A DBL OFFSET BROACH HDLE LT BROKE DURING USE. IT IS UNKNOWN HOW THE EVENT HAPPENED. NO INFORMATION ABOUT HOW THE PROCEDURE WAS FINISHED WAS PROVIDED AND IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713267 ↗
• MalfunctionApr 15, 2021Break; Incomplete or Inadequate Connection; Break; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, FOR 2 DBL OFFSET BROACH HDLE LT, THEY WERE BROKEN AND DID NOT LOCK ON THE BROACH PROPERLY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671423 ↗
• MalfunctionApr 15, 2021Break; Incomplete or Inadequate Connection; Break; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, FOR 2 DBL OFFSET BROACH HDLE LT, THEY WERE BROKEN AND DID NOT LOCK ON THE BROACH PROPERLY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671410 ↗
• MalfunctionApr 2, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING A THR PROCEDURE, THE DBL OFFSET BROACH HDLE LEFT WILL NOT HOLD BROACH TIGHTLY. INSTRUMENTS WERE INSIDE THE PATIENT. THERE WAS A SLIGHTLY DELAY OF ABOUT LESS THAN OR EQUAL TO 30 MINUTES. PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610887 ↗
• MalfunctionMar 28, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING THR SURGERY THE DBL OFFSET BROACH HDLE LT WOULD NOT ENGAGE THE BROACH COMPLETELY, SO WHEN CHECKING THE BROACH SIZE THE HANDLE WOULD MOVE, NOT ALLOWING THE SURGEON TO JUDGE IF TO UP OR NOT. THE SURGEON USED A SMITH AND NEPHEW BACKUP DEVICE TO CHECK AND GO UP IN SIZE. NO DELAY WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580410 ↗
• MalfunctionMar 1, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE BROACH TOGGLES WHEN ATTACHED TO HANDLE. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391229 ↗
• MalfunctionJan 30, 2021Connection Problem; Connection Problem

  IT WAS REPORTED BEFORE A THR PROCEDURE THAT THE BROACH HANDLE DID NOT HOLD THE BROACH. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING A BACKUP FROM SMITH & NEPHEW. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED AT THE MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11256313 ↗

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