MAUDE Adverse Event Report: SMITH & NEPHEW, INC.; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	210439
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was drilling patients bone in patients right foot when the tip of the drill bit broke off.Both pieces were obtained.Imaging was completed and confirmed there were no pieces of the drill bit left in the patient's wound.

• Brand Name: NA
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 7135 goodlett farms pkwy; cordova TN 38016
• MDR Report Key: 8925813
• Report Number: 8925813
• Device Sequence Number: 16215808
• 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): 08/06/2019
• Report Date (Section F): 08/06/2019

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
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2019
• 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: 08/06/2019