NA 03.122.056Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982074867), received between Jul 19, 2019 and Oct 27, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON COMPLAINED THAT THE TAB THAT HOUSES THE K WIRE WAS SHAVED OFF AND MISSING FROM THE GUIDE BLOCK. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389957 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON COMPLAINED THAT THE TAB THAT HOUSES THE K WIRE WAS SHAVED OFF AND MISSING FROM THE GUIDE BLOCK. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389948 ↗
• MalfunctionOct 30, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  ADDITIONAL EVENT INFORMATION STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20567404 ↗
• MalfunctionMar 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, THE INSERTION GUIDE WITH NOSE WAS MISPLACED, AND THE SURGEON PUT A K-WIRE THROUGH THE HOLE. THE K-WIRE BECAME STUCK IN THE HOLE, AND AS A RESULT THE DRILL GUIDE IS NO LONGER USEABLE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THIS REPORT IS FOR AN INSERTION GUIDE WITH NOSE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583019 ↗
• MalfunctionNov 8, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE USING THE PROXIMAL HUMERUS GUIDE BLOCK, KWIRE BROKE OFF INTO THE PIN HOLE AND WILL NOT COME OUT. ANOTHER SMALL FRAGMENT WAS OPENED TO COMPLETE THE PROCEDURE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH 5MIN OF SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THIS REPORT IS FOR ONE (1) INSERTION GUIDE WITH NOSE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15751235 ↗
• MalfunctionNov 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE, A WIRE BECAME STUCK IN THE K-WIRE SLOT OF THE PHILOS GUIDE. THIS REPORT IS FOR A PHILOS AIM-DEVICE W/NOSE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15734140 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON DESCRIBED AN INCIDENT THAT OCCURRED DURING HER RESIDENCY WHERE A PROXIMAL HUMERUS GUIDE BLOCK WAS CLOSED IN THE WOUND. THEN, POSTOPERATIVELY, THE PATIENT WAS BROUGHT BACK INTO THE OPERATING ROOM TO REMOVE THE GUIDE BLOCK ON AN UNKNOWN DATE. THE RESIDENCY TOOK PLACE BETWEEN 2011 - 2016. THE PATIENT WAS STABLE AFTER REMOVING THE GUIDE BLOCK. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE INSERTION GUIDE WITH NOSE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15630917 ↗
• InjuryJul 19, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE, THE PHILOS AIMING DEVICE HAS BEEN FORGOTTEN IN THE PATIENT AS IT REMAINED ATTACHED TO AN UNKNOWN IMPLANTED PLATE AFTER THE CLOSURE OF THE WOUND. THE SURGEON DISCOVERED THE ISSUE VIA CONTROL X-RAY THAT WAS MADE AFTER THE SURGERY. THUS, THE PATIENT IMMEDIATELY READMITTED IN THE OPERATING ROOM (OR) IN ORDER TO APPROACH THE PLATE THROUGH THE SAME INCISION. AN AIMING DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND RETURNED WITHIN THE INSTRUMENT SET. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT CONDITION WAS FINE. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) INSERTION GUIDE WITH NOSE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 8808533 ↗