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REFLECTION 71362915Recalls & reported problems

Smith & Nephew, Inc. · REFLECTION FLEXIBLE DRILL 15MM · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010464651), received between Dec 16, 2021 and Mar 30, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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

Device problems

  • Break2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 30, 2023Break; Break

    IT WAS REPORTED THAT, DURING A THR SURGERY, WHILE TRYING TO DRILL ON AN ANGLE INTO AN ACETABULAR CUP, ONE (1) FLEXIBLE DRILL 25MM, AND FLEXIBLE DRILL 15MM BROKE, AND ONE (1) FLEXIBLE DRILL 35MM, AND FLEXIBLE DRILL 15MM, TWISTED, BEFORE BEING ABLE TO COMPLETE THE DRILL HOLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16645240 ↗
  • MalfunctionDec 16, 2021Break; Break

    IT WAS REPORTED THAT DURING SURGERY, THE FLEXIBLE DRILL 15MM TWISTED OFF, BREAKING NEAR THE HEAD (SEE PICTURE). THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13019840 ↗

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

Other Prosthesis, hip, femoral component, cemented, metal devices

All Prosthesis, hip, femoral component, cemented, metal devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.