BALL NOSE GUIDE WIRERecalls & reported problems across all models

We found 3 models of BALL NOSE GUIDE WIRE by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Dec 27, 2019 and Oct 10, 2023 — classified as 2 injuries, 2 malfunctions.

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

2 FDA recall records 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

BALL NOSE GUIDE WIRE 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. Aug 21, 2019Class IITerminated

   Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

   Z-0531-2020 · Root cause: Environmental control · Recall details · FDA record ↗

2. Aug 21, 2019Class IITerminated

   Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

   Z-0530-2020 · Root cause: Environmental control · names 2 of these models · Recall details · FDA record ↗

Most reported BALL NOSE GUIDE WIRE problems

BALL NOSE GUIDE WIRE models

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

• BALL NOSE GUIDE WIRE 2810-01-100

  Guide, surgical, instrument
  1 recall3 reports
• BALL NOSE GUIDE WIRE 2810-01-080

  Guide, surgical, instrument
  1 recall1 report
• BALL NOSE GUIDE WIRE 2810-17-006

  Guide, surgical, instrument
  1 recall0 reports

Recent BALL NOSE GUIDE WIRE adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2023Fracture; Fracture

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

  Patient problems: Foreign Body In Patient

  MAUDE report 17904490 ↗
• InjuryMar 7, 2023Fracture; Fracture

  IT WAS FURTHER REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY APPROXIMATELY 2 MONTHS AGO. SUBSEQUENTLY, DURING THE PROCEDURE THE FEMORAL SHAFT WAS FOUND TO BE VERY DENSE, AND IT WAS DECIDED TO PERFORM MOTORIZED REAMING. DURING THE REAMING, THE GUIDE PIN FRACTURED LEAVING PART OF THE PIN IN THE FEMORAL SHAFT. THE SURGERY COULD NOT BE COMPLETED DUE TO A LACK OF NECESSARY EQUIPMENT AS THE SURGEON NOW NEEDED TO COMPLETE A FEMOROTOMY AND IMPLANT A LONG REVISION STEM. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WHERE THE SURGERY WAS COMPLETED A DAY LATER.

  Patient problems: Foreign Body In Patient

  MAUDE report 16499635 ↗
• MalfunctionDec 22, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE INNER STERILE PACKAGING FOR THE DEVICE WAS DAMAGED. SUBSEQUENTLY, ANOTHER DEVICE HAD TO BE OPENED AND USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13062787 ↗
• MalfunctionDec 27, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THERE IS A HOLE IN INTERNAL AND EXTERNAL PACKAGING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9523129 ↗

Other Biomet Orthopedics, LLC products

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