NA 71364073Recalls & reported problems

Summary

The FDA's MAUDE database contains 436 adverse event reports that list this exact device (DI 03596010507570), received between Aug 22, 2018 and May 5, 2026 — classified as 56 injuries, 380 malfunctions.

The most frequently reported specific device problem is “Break” (300 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 436 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT DURING A THR SURGERY, THE MI Z HANDLE ACET REAMER BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089276 ↗
• MalfunctionApr 11, 2026Break

  IT WAS REPORTED THAT, DURING THR SURGERY, THE MI Z HANDLE ACET REAMER 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 24846267 ↗
• MalfunctionFeb 27, 2026Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, MI Z HANDLE ACET REAMER SNAPPED AND BROKE APART AT THE JUNCTION/ CONNECTION POINT FOR OFFSET REAMER ATTACHMENT, AFTER REAMING FOR THE CUP. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470056 ↗
• MalfunctionFeb 13, 2026Break

  IT WAS REPORTED THAT, DURING A THR SURGERY ONE (1) MI Z HANDLE ACET REAMER AND ONE (1) R3 OFFSET IMPACTOR TIP BROKE ON SURGEON WHILE HE WAS REAMING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333838 ↗
• MalfunctionJan 29, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA, ONE (1) MI Z HANDLE ACET REAMER BROKE IN THREE PARTS. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. 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 24215511 ↗
• MalfunctionJan 19, 2026Break

  IT WAS REPORTED THAT, DURING A TOTAL HIP PROCEDURE, ONE (1) MI Z HANDLE ACET REAMER 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 24109000 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE SPRING MECHANISM OF ONE (1) MI Z HANDLE ACET REAMER BROKE WHILE REAMING. 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 24077365 ↗
• MalfunctionJan 13, 2026Fracture; Mechanics Altered

  IT WAS REPORTED THAT DURING A THA, THE JOINT OF ONE (1) MI Z HANDLE ACET REAMER THAT CONNECTS TO THE PART THAT LOCKS AND SPINS THE REAMER, BROKE INTO 2 PIECES, AND IT WOULD NO LONGER SPIN. 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 24058009 ↗
• MalfunctionJan 2, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE INTERIOR OF ONE (1) MI Z HANDLE ACET REAMER BROKE OFF WHEN SURGEON REAMED THE ACETABULUM. NO DEBRIS WAS FOUND IN THE WOUND. SURGEON WASHED CORRECTLY THE WOUND WITH WATER AFTER THE SURGERY. 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 23943477 ↗
• MalfunctionDec 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ANTERIOR TOTAL HIP ARTHROPLASTY, ONE (1) MI Z HANDLE ACET REAMER SNAPPED OFF WHILE REAMING WHERE THE HANDLE HINGES. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, OR IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906199 ↗
• MalfunctionDec 10, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) REAMER HANDLE BROKE WHILE IN USE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23773850 ↗
• MalfunctionNov 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) MI Z HANDLE ACET REAMER STOPPED WORKING, WHEN CHECKING WHAT WAS HAPPENING IT IS EVIDENT THAT IT IS BROKEN INTERNALLY AT THE HANDLE. NOTHING REMAINED INSIDE THE PATIENT. 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 23513276 ↗
• MalfunctionNov 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT, A MI Z HANDLE ACET REAMER WAS BROKEN DURING SURGERY. NOTHING WAS LEFT IN PATIENT. 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 23460403 ↗
• MalfunctionOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A PRIMARY TOTAL HIP SURGERY, IT WAS NOTICED THAT THE ADAPTER/CONNECTOR ON THE SHAFT OF ONE (1) MI Z HANDLE ACET REAMER BROKE. ALL PIECES WERE ACCOUNTED. 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 23301897 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, IT WAS NOTICED THAT ONE (1) MI Z HANDLE ACET REAMER 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 23295484 ↗
• MalfunctionOct 8, 2025Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT, DURING A THR SURGERY ONE (1) MI Z HANDLE ACET REAMER LOST TORQUE AND WAS NOT SPINNING FREELY. IT IS SUSPECTED A MECHANICAL JAM LEAD TO THE INSERT THAT ROTATES WITHIN THE HANDLE SNAPPING IN TWO. NO BROKEN PIECES WERE REQUIRED TO BE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23248074 ↗
• MalfunctionOct 7, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, IT WAS NOTICED THAT THE INSERT OF ONE (1) MI Z HANDLE ACET REAMER BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23238102 ↗
• MalfunctionSep 16, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) MI Z HANDLE ACET REAMER BROKE UPON REAMING. NO PIECE LEFT IN THE PATIENT. 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 23069074 ↗
• MalfunctionAug 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY WHILE REAMING THE ACETABULUM, THE SURGEON LEVERED ONE (1) MI Z HANDLE ACET REAMER CAUSING IT TO BIND AND IT BROKE AT THE CONNECTOR WHERE THE DEVICE ATTACHES. NO PIECE FELL IN THE WOUND. ALL PARTS WERE RECOVERED AND REMOVED FROM THE SURGICAL FIELD BY HAND. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A SN BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22889656 ↗
• MalfunctionAug 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THR SURGERY WHILE REAMING THE CONNECTION PIECE OF ONE (1) MI Z HANDLE ACET REAMER BROKE OFF AT THE U JOINT. THE PROCEDURE WAS COMPLETED WITHOUT 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 22873345 ↗
• MalfunctionAug 4, 2025Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY, ONE MI Z HANDLE ACET REAMER LOCKED UP. AFTER DISASSEMBLING THE DEVICE INTO PARTS 1, 2, AND 3, IT WAS NOTICED THAT PART 2 HAD BROKEN IN HALF. NO PIECE FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL 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 22710180 ↗
• MalfunctionJul 13, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE JUNCTION AT THE END OF THE MI Z HANDLE ACET REAMER BROKE. 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 22491099 ↗
• MalfunctionJul 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) MI Z HANDLE ACET REAMER SHAFT BROKE AT BASE WHEN REAMING. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, WITH 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 22437175 ↗
• InjuryJul 3, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THR, WHILE THE SURGEON WAS REAMING FOR A 51 SIZE WITH ONE (1) MI Z HANDLE ACET REAMER, IT BROKE INTERNALLY AND CAUSED A SMALL DEFORMITY. IT WAS NECESSARY TO REAM UP TO A SIZE 53 WITH A STANDARD STRAIT REAMER HANDLE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Laceration(s)

  MAUDE report 22395613 ↗
• MalfunctionJun 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A MI Z HANDLE ACET REAMER BROKE WHILE REAMING. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 22356726 ↗

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