NA 02.111.500.10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20886982031676), received between Feb 25, 2021 and Feb 25, 2021 — classified as 2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, THREE DEPTH GAUGES WERE BROKEN IN THE PROCESS OF MEASURING, THE TIPS COMPLETELY BROKE OFF. A TOTAL OF SEVEN WIRES BROKE OFF THE OLIVE TIPS, THE CANNULATED SCREWDRIVER WAS BROKEN, AND TWO T8'S WERE STRIPPED. THE PARALLEL GUIDE AND COUNTERSINK HAD RUST RESIDUE ON THEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: 2.0/2.4MM DEPTH GAUGE 50MM (PART NUMBER SD319.006, LOT UNKNOWN, QUANTITY 1) CANNULATED COUNTERSINK FOR 4.5MM CANNULATED SCREWS (PART NUMBER 310.85, LOT UNKNOWN, QUANTITY 1). ADJUSTABLE PARALLEL WIRE GUIDE (PART NUMBER 312.73, LOT UNKNOWN, QUANTITY 1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER (PART NUMBER 314.05, LOT UNKNOWN, QUANTITY 1) STARDRIVE SCREWDRIVER SHAFT T8 105MM (PART NUMBER 314.467, LOT UNKNOWN, QUANTITY 1) 1.25MM PLATE REDUCTION WIRE THRDD TIP W/SM STOP/150MM (PART NUMBER 02.111.500.10, LOT UNKNOWN, QUANTITY 1). 1.6MM COMPRESSION WIRE 15MM THREAD/150MM LENGTH (PART NUMBER 03.211.415, LOT UNKNOWN, QUANTITY 1). 2.0/2.4MM DEPTH GAUGE 50MM (PART NUMBER SD319.006, LOT UNKNOWN, QUANTITY 2). THIS REPORT INVOLVES ONE (1) 1.25MM PLATE R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378747 ↗
• MalfunctionFeb 25, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE, THREE DEPTH GAUGES WERE BROKEN IN THE PROCESS OF MEASURING, THE TIPS COMPLETELY BROKE OFF. A TOTAL OF SEVEN WIRES BROKE OFF THE OLIVE TIPS, THE CANNULATED SCREWDRIVER WAS BROKEN, AND TWO T8'S WERE STRIPPED. THE PARALLEL GUIDE AND COUNTERSINK HAD RUST RESIDUE ON THEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: 2.0/2.4MM DEPTH GAUGE 50MM (PART NUMBER SD319.006, LOT UNKNOWN, QUANTITY 1) CANNULATED COUNTERSINK FOR 4.5MM CANNULATED SCREWS (PART NUMBER 310.85, LOT UNKNOWN, QUANTITY 1). ADJUSTABLE PARALLEL WIRE GUIDE (PART NUMBER 312.73, LOT UNKNOWN, QUANTITY 1) CANNULATED 4.0MM HEXAGONAL SCREWDRIVER (PART NUMBER 314.05, LOT UNKNOWN, QUANTITY 1) STARDRIVE SCREWDRIVER SHAFT T8 105MM (PART NUMBER 314.467, LOT UNKNOWN, QUANTITY 1) 1.25MM PLATE REDUCTION WIRE THRDD TIP W/LRG STOP/150MM (PART NUMBER 02.111.501.10, LOT UNKNOWN, QUANTITY 1). 1.6MM COMPRESSION WIRE 15MM THREAD/150MM LENGTH (PART NUMBER 03.211.415, LOT UNKNOWN, QUANTITY 1). 2.0/2.4MM DEPTH GAUGE 50MM (PART NUMBER SD319.006, LOT UNKNOWN, QUANTITY 2). THIS REPORT INVOLVES ONE (1) 1.25MM PLATE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11378536 ↗