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

Model Number	00-4836-270-25
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A piece of the 2.5 drill bit broke off in the patient's bone.

• Brand Name: NA
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• MDR Report Key: 15163269
• Report Number: 15163269
• Device Sequence Number: 20266710
• Product Code: HTW
• UDI-Device Identifier: 00889024073753
• UDI-Public: (01)00889024073753
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/13/2022
• Report Date (Section F): 07/13/2022

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: 00-4836-270-25
• Device Catalogue Number: 00-4836-270-25
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2022
• 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: Male
• Patient Weight: 130 KG
• Date Report Sent to FDA: 07/13/2022