MAUDE Adverse Event Report: SMITH NEPHEW, INC. TWIST DRILL 2.0MM DIA 127.0MM LONG; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	210439
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure a drill bit broke.All pieces were recovered and taken away from the surgical field.X-ray was taken per policy.Radiologist phoned into room, reported directly to surgeon, no foreign object.Procedure was finished without further incident.Patient discharged to pacu.Drill bit pieces given to supervisor.

• Brand Name: TWIST DRILL 2.0MM DIA 127.0MM LONG
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 15369559
• Report Number: 15369559
• Device Sequence Number: 1829652
• Product Code: KTT
• UDI-Device Identifier: 03596010102560
• UDI-Public: (01)03596010102560
• 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): 08/31/2022
• Report Date (Section F): 08/31/2022

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: 210439
• Device Catalogue Number: 210439
• Device Lot Number: 32048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 08/31/2022