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

Model Number 71175022

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/26/2021

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 241433898
• Report Number: 11541782
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00885556635766
• UDI-Public: (01)00885556635766
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71175022
• Device Catalogue Number: 71175022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18615 DA