NA 705800Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327409666), received between Sep 2, 2020 and Oct 5, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2020Fracture; Fracture

  SURGEON PERFORMED A TIBIO-CALCANEAL JOINT FUSION WITH USE OF AN ANTERIOR STANDARD PLATE AND ADDITIONAL FIXATION MATERIAL. HER FEEDBACK INCLUDED THE FOLLOWING: ¿ALL 3 OLIVES BROKE ABOVE THE OLIVE (INDICATED AS AN IDENTIFIED AREA FOR IMPROVEMENT FOR AVAILABLE INSTRUMENTS)." SALES REPRESENTATIVE ADDITIONALLY REPORTED THAT THE EVENT OCCURRED, "DURING THE EXTRACTION FROM THE PLATE. I THINK THEY HAD THE DRIVER IN FORWARD AND THE TORQUE SNAPPED IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10631981 ↗
• MalfunctionOct 5, 2020Fracture; Fracture

  SURGEON PERFORMED A TIBIO-CALCANEAL JOINT FUSION WITH USE OF AN ANTERIOR STANDARD PLATE AND ADDITIONAL FIXATION MATERIAL. HER FEEDBACK INCLUDED THE FOLLOWING: ¿ALL 3 OLIVES BROKE ABOVE THE OLIVE.¿ [INDICATED AS AN IDENTIFIED AREA FOR IMPROVEMENT FOR AVAILABLE INSTRUMENTS] SALES REPRESENTATIVE ADDITIONALLY REPORTED THAT THE EVENT OCCURRED, "DURING THE EXTRACTION FROM THE PLATE. I THINK THEY HAD THE DRIVER IN FORWARD AND THE TORQUE SNAPPED IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10631921 ↗
• MalfunctionOct 5, 2020Fracture; Fracture

  SURGEON PERFORMED A TIBIO-CALCANEAL JOINT FUSION WITH USE OF AN ANTERIOR STANDARD PLATE AND ADDITIONAL FIXATION MATERIAL. HER FEEDBACK INCLUDED THE FOLLOWING: ¿ALL 3 OLIVES BROKE ABOVE THE OLIVE.¿ INDICATED AS AN IDENTIFIED AREA FOR IMPROVEMENT FOR AVAILABLE INSTRUMENTS. SALES REPRESENTATIVE ADDITIONALLY REPORTED THAT THE EVENT OCCURRED "DURING THE EXTRACTION FROM THE PLATE. I THINK THEY HAD THE DRIVER IN FORWARD AND THE TORQUE SNAPPED IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10631887 ↗
• MalfunctionSep 18, 2020Fracture; Fracture

  AS REPORTED: ""THE PLACE HOLDER PINS BROKE OFF.¿"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10557248 ↗
• MalfunctionSep 18, 2020Fracture; Fracture

  AS REPORTED: ""THE PLACE HOLDER PINS BROKE OFF.¿"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10557246 ↗
• MalfunctionSep 2, 2020Fracture; Fracture

  IT WAS REPORTED: "DOCTOR PERFORMED A TIBIO-TALAR JOINT FUSION WITH USE OF AN ANTEROLATERAL STANDARD PLATE AND AN INDEPENDENT 6.5 CANNULATED SCREW. HER FEEDBACK IS MAINLY POSITIVE; HOWEVER A DRILL BIT (705025) AND AN OLIVE WIRE BROKE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10484103 ↗