2.0MM SYSTEM 01-9193Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841036016937), received between Apr 10, 2020 and Mar 13, 2025 — classified as 1 injury, 3 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K062842); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 13, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593115 ↗
• MalfunctionApr 12, 2022Fracture

  IT WAS REPORTED THAT THE DEVICE FRACTURED DURING A PROCEDURE AND A PIECE COULD NOT BE LOCATED. X-RAYS WERE PERFORMED, AND NO PIECE OF THE DEVICE WAS LOCATED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083986 ↗
• InjuryJun 3, 2020Flaked; Flaked

  IT WAS REPORTED THE PATIENT RETAINED A FOREIGN BODY AFTER PAINT FLAKED OFF OF DRILL BITS. AFTER DRILLING THE HOLES, THE SURGEON NOTED THE PAINT ON THE DRILL BITS WAS MISSING. SOME BUT NOT ALL OF THE PEELED PAINT WAS LOCATED IN THE SUCTION TANK. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10115403 ↗
• MalfunctionApr 10, 2020Flaked; Flaked

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9949757 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062842. One submission often covers many models, so check the product and lot details in each record.

• Z-0538-2010 · Nov 6, 2009 · Terminated
  Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J NOTCH, REF 01-7141. DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218