NA 03.168.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982274496), received between Jul 24, 2020 and Jul 23, 2025 — classified as 3 malfunctions.

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

• MalfunctionJul 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE THE TRILEAP MPJ PLATE WAS USED AND SCREW DID NOT LOCK IN, UNSURE IF IT WAS BECAUSE USED A CONICAL EXTRACTOR TO REMOVE SCREW. 2.0 PLATE ALSO DID NOT LOCK IN. RUST ON GRAPHIC CASES AND INSTRUMENTS TO BE REPLACED. THERE WAS NO PATIENT CONSEQUENCES. (B)(4) ARE RELATED TO EACH OTHER. (B)(4) IS CREATED TO CAPTURE THE ADDITIONAL IPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22575048 ↗
• MalfunctionJul 22, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE THE TRILEAP MPJ PLATE WAS USED AND SCREW DID NOT LOCK IN, UNSURE IF IT WAS BECAUSE USED A CONICAL EXTRACTOR TO REMOVE SCREW. 2.0 PLATE ALSO DID NOT LOCK IN. RUST ON GRAPHIC CASES AND INSTRUMENTS TO BE REPLACED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22567701 ↗
• MalfunctionJul 24, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE OSTEOSYNTHESIS SURGERY FOR FEMORAL NECK FRACTURES. DURING THE SURGERY, THE SURGEON HAD DIFFICULTIES IN PLACING THE ANGLED GUIDE ON THE BONE SURFACE. IT COULD NOT BE PLACED IN A STABLE STATE WHEN HE TRIED TO INSERT A GUIDE WIRE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A THIRTY (30) MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN GUIDEWIRE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 130 DEGREE ANGLED GUIDE FOR 3.2MM GUIDE WIRES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10321111 ↗