NA 71362754Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010456922), received between Jul 29, 2019 and May 18, 2026 — classified as 2 injuries, 5 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 18, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) REAMER DOME 54MM EXPERIENCED BREAKAGE OF THE X-SHAPED COMPONENT THAT CONNECTS THE REAMER DOME TO THE REAMER HANDLE 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 25211513 ↗
• MalfunctionJan 22, 2026Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE REAMER ATTACHMENT BARS OF ONE (1) REAMER DOME 54MM BROKE OFF. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THIS CAUSED ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24145747 ↗
• MalfunctionAug 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, WHEN FRAZING THE ACEBULAR, THERE WAS A BREAKAGE OF THE REAMER DOME 54MM CUTTER, DUE TO HIGH RESISTANCE AND GOOD BONE QUALITY. PIECE WAS COMPLETELY REMOVED BY THE SURGEON. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO HARM TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19960964 ↗
• InjuryJun 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING THR SURGERY, THE PHYSICIAN WAS REAMING THE ACETABULUM WHEN THE CROSSBAR ON THE REAMER DOME 54MM BECAME DETACHED FROM THE REAMER. THE DETACHED PIECE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640483 ↗
• MalfunctionMar 28, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE REAMER DOME 54MM FRAME BROKE UPON INTRODUCING INTO ACETABULUM. NO PIECE FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13927024 ↗
• InjuryAug 10, 2020Break; Break

  IT WAS REPORTED THAT THE CROSSBARS OF THE REAMER DOME BROKE DURING REAMING. STAFF WAS ABLE TO GET ALL PIECES, RETRIEVE THE DOME, OPEN ANOTHER SET AND CONTINUE CASE. THE REAMER DOME WAS STUCK, BUT IT GOT OUT. SLIGHT DELAY TO OPEN ANOTHER REAMER TRAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10388407 ↗
• MalfunctionJul 29, 2019Break; Break

  IT WAS REPORTED THAT DURING A THA PROCEDURE, REAMER BROKE DURING REAMING THE ACETABULUM. DELAY FORM 30 MINUTES TO 1 HOUR REPORTED. BACKUP DEVICE AVAILABLE. NO IMPACT OR INJURY TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8839842 ↗

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