NA 71360090Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 03596010610362), received between Feb 6, 2019 and Apr 9, 2022 — classified as 6 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Break” (24 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 65 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2022Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT, DURING A THR, A DOUBLE OFFSET BROACH HANDLE RIGHT BROKE WHILE BROACHING WITH MALLET BROACH AND WOULD NOT CONNECT SECURELY. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14068187 ↗
• InjuryNov 9, 2021Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY DURING SMACKING THE DBL OFFSET BROACH HDLE RT, THE MECHANISM THAT CAPTURES THE HEAD OF THE BROACH BECAME BROKEN. SURGERY WAS FINISHED WITH A S&N BACK UP DEVICE, WITHOUT ANY SURGICAL DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12782170 ↗
• MalfunctionOct 8, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, A DBL OFFSET BROACH HANDLE RT BROKE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING USE IN PATIENT AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12598079 ↗
• MalfunctionSep 27, 2021Break; Loose or Intermittent Connection; Naturally Worn; Break; Loose or Intermittent Connection; Naturally Worn

  IT WAS REPORTED THAT, DURING A THR SURGERY A DBL OFFSET BROACH HANDLE RT WAS BROKEN, NOT COMPLETELY BROKEN BUT CLAMPING/GRIP OF INSTRUMENT IS WORN AND DOES NOT GRIP THE LOCK THE BROACH AS WELL ANYMORE. SURGERY WAS FINISHED WITH THE SAME DEVICE WITH LESS THAN 30 MINUTES OF SURGICAL DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533995 ↗
• InjurySep 23, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A DBL OFFSET BROACH HANDLE RT WAS FOUND BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IF IT THERE WAS A SURGICAL DELAY. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12523828 ↗
• MalfunctionJun 24, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT TWO (2) DBL OFFSET BROACH HDLE RIGHT HAVE WORN DOWN AND NO LONGER HOLD THE BROACH SECURELY. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12063673 ↗
• MalfunctionJun 22, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE DBL OFFSET BROACH HDLE RT IS NOT HOLDING SECURELY. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042927 ↗
• MalfunctionJun 22, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT A RIGHT DUAL OFFSET BROACH HANDLE IS NO LONGER HOLDING SECURELY. THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042914 ↗
• MalfunctionJun 2, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING THR SURGERY, A DBL OFFSET BROACH HDLE RT WAS NOT FULLY HOLDING THE BROACH WHILE RETRACTING IT BACK FROM THE FEMUR. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED DUE TO THIS EVENT AS A SMITH AND NEPHEW BACKUP DEVICE WAS AVAILABLE TO CONCLUDE THE PROCEDURE. NEITHER PATIENT INJURY NOR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11922210 ↗
• MalfunctionMay 28, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING SET UP FOR TKA, IT WAS FOUND THAT THREE (3) DBL OFFSET BROACH HANDLES RT, WERE VERY LOOSE ON BROACH AND LENT TO THE ILLUSION OF POOR CORTICAL CONTACT AND STABILITY. NO SURGICAL DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK-UP DEVICE. 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 11904603 ↗
• MalfunctionMay 28, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING SET UP FOR TKA, IT WAS FOUND THAT THREE (3) DBL OFFSET BROACH HANDLES RT, WERE VERY LOOSE ON BROACH AND LENT TO THE ILLUSION OF POOR CORTICAL CONTACT AND STABILITY. NO SURGICAL DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK-UP DEVICE. 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 11904584 ↗
• MalfunctionMay 28, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING SET UP FOR TKA, IT WAS FOUND THAT THREE (3) DBL OFFSET BROACH HANDLES RT, WERE VERY LOOSE ON BROACH AND LENT TO THE ILLUSION OF POOR CORTICAL CONTACT AND STABILITY. NO SURGICAL DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK-UP DEVICE. 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 11904580 ↗
• InjuryMay 13, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THR SURGERY THE IMPACTION PLATFORM SEPARATED FROM THE DBL OFFSET BROACH HDLE RT. A SMITH AND NEPHEW BACKUP DEVICE WAS AVAILABLE. NO INJURY OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11819733 ↗
• MalfunctionMay 12, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A THR SURGERY THE DBL OFFSET BROACH HDLE RT WOULD NOT LOCK ONTO THE BROACH. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. NO PATIENT INJURIES AND NO 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 11813355 ↗
• MalfunctionMay 11, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, THE DBL OFFSET BROACH HANDLE RT DID NOT HOLDING SECURELY. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810123 ↗
• MalfunctionMay 11, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, THE DBL OFFSET BROACH HDLE RT DID NOT HOLDING SECURELY. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810115 ↗
• MalfunctionMay 10, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A THR, A DBL OFFSET BROACH HDLE RT DID NOT LOCK IN PLACE PROPERLY ON THE RASPS. 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 11798231 ↗
• MalfunctionApr 27, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE DBL OFFSET BROACH HDLE RT NO LONGER HOLDS THE BROACH WELL. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11735893 ↗
• MalfunctionApr 27, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE DBL OFFSET BROACH HDLE RT RELEASES FROM BROACH WHEN STRUCK. INSTRUMENT WAS BEING USED 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 11735145 ↗
• MalfunctionApr 26, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A THR, THE DBL OFFSET BROACH HDLE RT WAS NOT PROPERLY LOCKING AND HOLDING. THERE WAS NOT SURGICAL DELAY REPORTED AND THE SURGERY WAS COMPLETED WITH A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729680 ↗
• MalfunctionApr 26, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A THR, THE DBL OFFSET BROACH HDLE RT WAS NOT PROPERLY LOCKING AND HOLDING. THERE WAS NOT SURGICAL DELAY REPORTED AND THE SURGERY WAS COMPLETED WITH A BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729679 ↗
• MalfunctionApr 15, 2021Break; Break

  IT WAS REPORTED THAT, 3 DBL OFFSET BROACH HDLE RT AND 1 R3 3 HOLE ACET SHELL 50MM WERE BROKEN AND DID NOT LOCK ON TO THE BROACH PROPERLY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671744 ↗
• MalfunctionApr 15, 2021Break; Break

  IT WAS REPORTED THAT, 3 DBL OFFSET BROACH HDLE RT AND 1 R3 3 HOLE ACET SHELL 50MM WERE BROKEN AND DID NOT LOCK ON TO THE BROACH PROPERLY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671440 ↗
• MalfunctionApr 15, 2021Break; Break

  IT WAS REPORTED THAT, 3 DBL OFFSET BROACH HDLE RT AND 1 R3 3 HOLE ACET SHELL 50MM WERE BROKEN AND DID NOT LOCK ON TO THE BROACH PROPERLY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671434 ↗
• MalfunctionApr 15, 2021Break; Break

  IT WAS REPORTED THAT, 3 DBL OFFSET BROACH HDLE RT AND 1 R3 3 HOLE ACET SHELL 50MM WERE BROKEN AND DID NOT LOCK ON TO THE BROACH PROPERLY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671418 ↗

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