MAUDE Adverse Event Report: ZIMMER, INC.; BIT, DRILL

Model Number	2360-175-20
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: while using drill bit for surgery, said bit broke into two pieces while in use in patient.Broken piece was able to be removed from patient.Both pieces were obtained and saved.

• Brand Name: NA
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ZIMMER, INC.; 1800 w. center street; warsaw IN 46580
• MDR Report Key: 18464270
• Report Number: 18464270
• Device Sequence Number: 7192019
• Product Code: HTW
• UDI-Device Identifier: 00889024061095
• UDI-Public: (01)00889024061095
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2023
• Report Date (Section F): 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2360-175-20
• Device Catalogue Number: 00-2360-175-20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 114 KG
• Date Report Sent to FDA: 12/07/2023