MAUDE Adverse Event Report: SMITH NEPHEW, INC.; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO

Model Number	210439
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Smith and nephew drill bit 2.0 used on operative field broke while in use.Device removed from field.No harm to the patient.

• Brand Name: NA
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO
• Manufacturer (Section D): SMITH NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 15814756
• Report Number: 15814756
• Device Sequence Number: 12531167
• 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): 11/03/2022
• Report Date (Section F): 11/03/2022

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
• Device Model Number: 210439
• Device Catalogue Number: 210439
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 11/03/2022