DRILL BITRecalls & reported problems across all models

We found 3 models of DRILL BIT by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Dec 29, 2020 and May 23, 2023 — classified as 5 malfunctions.

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

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

DRILL BIT recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 14, 2022Terminated

   Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.

   Z-0812-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported DRILL BIT problems

DRILL BIT models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DRILL BIT 212000022

  BIT, DRILL
  1 recall3 reports
• DRILL BIT 2312-00-200

  BIT, DRILL
  1 report
• DRILL BIT 8290-29-070

  BIT, DRILL
  1 report

Recent DRILL BIT adverse event reports

The 5 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2023Packaging Problem; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16983150 ↗
• MalfunctionDec 30, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118231 ↗
• MalfunctionJun 11, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE STERILE PACKAGING WAS FOUND TO BE CUT DURING INCOMING INSPECTION. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11984207 ↗
• MalfunctionFeb 12, 2021Fracture; Fracture

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

  Patient problems: No Patient Involvement

  MAUDE report 11323043 ↗
• MalfunctionDec 29, 2020Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11088153 ↗

Other Biomet Orthopedics, LLC products

• AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
• AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
• Compress Device71 models · 99 reports · 22 recalls
• Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
• Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
• Vanguard Knee System147 models · 306 reports · 13 recalls
• STAGEONE17 models · 0 reports · 18 recalls
• StageOne Select15 models · 2 reports · 15 recalls