MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP. INSTRUMENT; BIT, DRILL

Model Number	6541-4-518
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was using a drill during this procedure and the drill bit broke while in use.All pieces of drill bit were found and removed from patient.

• Brand Name: INSTRUMENT
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP.; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8168756
• Report Number: 8168756
• Device Sequence Number: 13772927
• Product Code: HTW
• UDI-Device Identifier: 07613327241440
• UDI-Public: (01)07613327241440
• 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): 12/07/2018
• Report Date (Section F): 12/07/2018

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: No Information
• Device Model Number: 6541-4-518
• Device Catalogue Number: 6541-4-518
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/07/2018