REFLECTION 732109Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010258922), received between Jul 22, 2020 and Mar 3, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K093047); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, TWO (2) ACET ANGLED DEPTH GAUGE BROKE. EVERYTHING WAS RETRIEVED. SURGERY WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21505269 ↗
• MalfunctionMay 18, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT, DURING A THR SURGERY WHILE THE INSTRUMENTS WERE BEING USED INSIDE OF THE PATIENT, IT WAS NOTICED THAT THE SCREW SIZE OF THREE (3) ACET ANGLED DEPTH GAUGE WERE UNREADABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11846216 ↗
• MalfunctionMay 18, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT, DURING A THR SURGERY WHILE THE INSTRUMENTS WERE BEING USED INSIDE OF THE PATIENT, IT WAS NOTICED THAT THE SCREW SIZE OF THREE (3) ACET ANGLED DEPTH GAUGE WERE UNREADABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11846210 ↗
• MalfunctionMay 18, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT, DURING A THR SURGERY WHILE THE INSTRUMENTS WERE BEING USED INSIDE OF THE PATIENT, IT WAS NOTICED THAT THE SCREW SIZE OF THREE (3) ACET ANGLED DEPTH GAUGE WERE UNREADABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11846207 ↗
• MalfunctionJul 22, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THR PROCEDURE, EXTERNAL TO PATIENT, WAS NOTICED THAT THE ACET ANGLED DEPTH GAUGE WAS BENT AND WHEN TRYING TO BEND IT BACK, THE PRODUCT SNAPPED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH NO SURGICAL DELAY AND NO INJURY TO THE PATIENT.

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

  MAUDE report 10307400 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093047. One submission often covers many models, so check the product and lot details in each record.

• Z-0245-2022 · Jun 17, 2021 · Open, Classified
  Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434