REFLECTION 71362012Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010198624), received between May 27, 2019 and May 29, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2024Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, IT WAS NOTICED THAT, THE END OF A R3 DEPTH GAUGE NO LONGER HAS A HOOK TO GRAB THE BONE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING 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 19420700 ↗
• MalfunctionAug 22, 2022Break; Break

  IT WAS REPORTED THAT TWO (2) REFLECTION DEPTH GAUGE WERE BROKEN OFF. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15271707 ↗
• MalfunctionApr 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, THE TIP OF RF INTERFIT DEPTH GAUGE SNAPPED WHILE PREPPING FOR MEASUREMENT. THE BROKEN PIECE WAS RETRIEVED AND DID NOT GO INSIDE OF THE PATIENT. SURGERY WAS FINISHED, WITHOUT ANY DELAY, WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14022248 ↗
• MalfunctionNov 1, 2021Break; Break

  IT WAS REPORTED THAT, A RF INTERFIT DEPTH GAUGE IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12729766 ↗
• MalfunctionNov 4, 2019Illegible Information; Illegible Information

  IT WAS REPORTED THAT DURING SURGERY THE NUMBERS ON THE GAUGE WERE FADED AND HARD TO READ, THIS WAS DISCOVERED WHILE THE DEVICE WAS IN USED. S+N BACK-UP WAS AVAILABLE AND ONCE THE INCIDENT WAS NOTED THIS DEVICE WAS SWITCHED TO THIS ONE TO COMPLETE THE PROCEDURE. NO DELAY OR INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9273782 ↗
• MalfunctionJun 17, 2019Break; Break

  IT WAS REPORTED THAT DURING A THA PROCEDURE, DEPTH GAUGE BROKE IN HALF DUE TO NORMAL WEAR AND TEAR. DEVICE BROKE OVER THE PATIENT INCISION, ALL PIECES RECOVERED. NO DELAY. BACKUP DEVICE AVAILABLE. NO INJURY OR IMPACT TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8704313 ↗
• MalfunctionMay 27, 2019Break; Break

  IT WAS REPORTED THAT DURING THR WHEN THE LENGTH OF THE SCREW CHANNEL IS MEASURED BEFORE THE SCREW IS INSERTED, THE DEPTH GAUGE ENTERS THE SCREW CHANNEL AND BROKEN DURING THE MEASUREMENT. THE BROKEN PIECES WERE RECOVERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8643500 ↗

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