NA 71362755Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010456939), received between Jul 15, 2020 and Oct 19, 2023 — classified as 5 injuries, 3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE REAMER DOME 55MM ATTACHMENT ARMS SNAPPED DURING USE. ALL PARTS WERE RECOVERED. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S/N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966111 ↗
• InjuryJan 4, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE SURGEON WAS REAMING ACETABULUM AND THE REAMER DOME 55MM SNAPPED OFF FROM THE BASE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13152549 ↗
• MalfunctionFeb 9, 2021Solder Joint Fracture; Solder Joint Fracture

  IT WAS REPORTED THAT THE REAMER DOME DEVICE WAS FOUND WITH WELDS BROKEN. NO CASE INVOLVED; THEREFORE, NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11300576 ↗
• MalfunctionDec 9, 2020Break; Break

  IT WAS REPORTED THAT, DURING INSPECTION, THE REAMER DOME 55MM WAS NOTICED TO BE BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10976323 ↗
• InjurySep 17, 2020Break; Break

  IT WAS REPORTED THAT DURING A THR THE REAMER DOME 55MM WAS FOUND TO BE BROKEN, INTRAOPERATIVELY; THERE IS NO INFORMATION REGARDING HOW THE PROCEDURE WAS COMPLETED, NO DELAY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10549379 ↗
• InjuryJul 18, 2020Flaked; Flaked

  IT WAS REPORTED THAT AFTER THR PROCEDURE IT WAS NOTICED THAT THE REAMER WAS SHEDDING METAL INSIDE THE PATIENT. NO DELAY. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10293459 ↗
• InjuryJul 15, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE REAMER CROSS SUPPORT BROKE OUT OF THE REAMER DOME 55MM WHILE REAMING DURING A THR. THE DEVICE BROKE INSIDE THE PATIENT AND THE DEVICES HAD TO BE RETRIEVED. AN S&N BACKUP WAS NOT REQUIRED AS THE SURGERY WAS COMPLETED WITH THE SAME DEVICE. NO DELAY REPORTED. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED EVENT.

  Patient problems: No Information

  MAUDE report 10279222 ↗
• InjuryJul 15, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CROSS SUPPORT BROKE OUT OF THE 55 MM REAMER DOME WHILE REAMING INSIDE THE PATIENT. ALL PIECES WERE RETRIEVED FROM THE PATIENT. AN S&N BACKUP WAS NOT REQUIRED AS THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. THE PATIENT WAS NOT HARMED BEYOND THE DESCRIBED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10279160 ↗

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