NA 03.122.052Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982074843), received between Sep 6, 2023 and Sep 22, 2026 — classified as 4 malfunctions.

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

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Device Slipped; Detachment of Device or Device Component

  It was reported that on (b)(6) 2026, the patient underwent ORIF surgery on the upper arm. During surgery, the tip of the probe detached. Although it could be reattached, it became loose, so a different product was used. There was no impact on the patient. The surgery was completed successfully without any surgical delay. After the surgery, the product was returned to distribution center with a note attached indicating "instrument damage."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858467 ↗
• MalfunctionMar 20, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF WITH PHILOS IMPLANT FOR PROXIMAL HUMERUS FRACTURE. ON THE EVENING OF THE SURGERY, THE SALES REP RECEIVED FROM OUR DISTRIBUTOR THAT A DEPTH GAUGE WAS BROKEN OFF DURING THE SURGERY. THE SURGERY WAS COMPLETED USING AN ALTERNATIVE PRODUCT. THERE ARE NO PIECES IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY. THERE WERE NO ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT DUE TO THE REPORTED EVENT. THIS REPORT IS FOR ONE (1) LENGTH PROBE F/03.122.053+03.122.058 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944455 ↗
• MalfunctionFeb 14, 2024Break; Break

  IT WAS REPORTED THAT ON FEBRUARY 2, 2024, THE PATIENT UNDERWENT UNKNOWN SURGERY. A DEPTH GAUGE FOR PHILOS USE WAS USED FOR MEASUREMENT, AFTER THAT, IT WAS SEEN WHEN THE DEPTH GAUGE WAS PULLED FROM INTERNAL BONE THAT BOUNDARY LINE BETWEEN THIN EDGE PORTION AND DISPLAY OF MEMORY WAS SEPARATED. THE DEPTH GAUGE APPEARS NOT TO BE AVAILABLE, SO ONE FROM USF SERIES WAS ALSO USED FOR MEASUREMENT AT PROXIMAL SIDE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) LENGTH PROBE F/03.122.053+03.122.058 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)

  Patient problems: Insufficient Information

  MAUDE report 18703623 ↗
• MalfunctionSep 6, 2023Material Deformation; Illegible Information; Material Deformation; Illegible Information

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR A HUMERAL NECK FRACTURE. THE ENGRAVING ON THE SCALE OF THE DEPTH GAUGE WAS TOO WORN AND DIFFICULT TO READ, WHICH HINDERED THE SELECTION OF THE SIZE OF IMPLANT TO BE USED. THE SURGEON MANAGED TO READ THE SCALE BY REMOVING THE OPERATING LIGHT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE DEPTH PROBE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17692961 ↗