MAUDE Adverse Event Report: SMITH NEPHEW, INC. EVOS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	71175022
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During procedure tip of smith and nephew drill bit (7117-5022) broke in patients right tibia.Surgeon determined it would cause more harm than good to patient to retrieve drill bit.X-ray for foreign body obtained and read by radiologist negative for foreign body (unable to visualize on x-ray).

• Brand Name: EVOS
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11541782
• Report Number: 11541782
• Device Sequence Number: 4203931
• Product Code: HWE
• UDI-Device Identifier: 00885556635766
• UDI-Public: (01)00885556635766
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2021
• Report Date (Section F): 03/03/2021

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: 71175022
• Device Catalogue Number: 71175022
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2021
• 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: 03/03/2021