REFLECTION 71363654Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010479853), received between Jul 13, 2020 and Sep 5, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, (2) TRIAL 20 DEG 36MM 58-60G CENTER SCREWS BROKE. THE SURGERY WAS COMPLETED WITH THE SAME DEVICE. NO INJURIES OR DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15358682 ↗
• MalfunctionAug 16, 2021Break; Break

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION FOR A THR, THE INNER SCREW OF TWO TRIALS: A TRIAL 20 DEG 36MM 54-56 F AND A TRIAL 20 DEG ANT+4 36 54-56 F, BROKE AWAY FROM PLASTIC. SURGERY WAS COMPLETED WITHOUT ANY DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12325662 ↗
• MalfunctionJul 21, 2021Break; Break

  IT WAS REPORTED THAT, A TRIAL 20 DEG 36MM 54-56 F HAS A BROKEN SCREW. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12201253 ↗
• InjuryMar 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR THE LINER TRIAL 20 DEG 36MM 54-56 F BROKE WHEN INSERTING INTO CUP. INSTRUMENTS INSIDE THE PATIENT. ALL PIECES WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11587193 ↗
• MalfunctionFeb 26, 2021Break; Break

  IT WAS REPORTED THAT, THE TRIAL 20 DEG 36MM 54-56 F BROKE AT THE SCREW. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388734 ↗
• MalfunctionJul 13, 2020Break; Break

  IT WAS DISCOVERED THAT DURING SET UP IN THR PROCEDURE THE CENTER HOLE SCREW WAS FOUND BROKEN UPON OPENING THE TRAY. IT WAS NOT PUT IN THE PATIENT AS A BACKUP WAS AVAILABLE. NO DELAY OR INJURY REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10268340 ↗

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