MAUDE Adverse Event Report: CONMED CORPORATION MICRO 100; INSTRUMENT, CUTTING, ORTHOPEDIC

Model Number 5053-009

Device Problem Failure to Disconnect (2541)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/18/2022

Event Type  malfunction  

Event Description

While in the operating room, the surgeon was using a micro 100 drill on a patient.The micro 100 drill release got stuck and did not release the guide wire while it was in the patient.The wire remained stuck in the drill.A new drill had to be obtained during the surgery.

• Brand Name: MICRO 100
• Type of Device: INSTRUMENT, CUTTING, ORTHOPEDIC
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 15657341
• MDR Text Key: 302271772
• Report Number: 15657341
• Device Sequence Number: 1
• Product Code: HTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5053-009
• Device Catalogue Number: 5053-009
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1