REFLECTION 71362846Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010455291), received between Nov 13, 2019 and Nov 13, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE INSTRUMENT BROKE AT THE END OF THE PROCEDURE AT THE EXTREME, AND WAS IN CONTACT WITH THE PATIENT. THE SURGERY WAS STILL SUCCESSFULLY COMPLETED WITHOUT PATIENT DAMAGE. NO DELAY OR INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9319015 ↗

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