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

Model Number	71175022
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A one inch piece of 2.5 mm drill bit broke off deep in the tibia bone.The surgeon opted to leave the broken piece as it would be more detrimental to patient to try to retrieve it.

• 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: 11705967
• Report Number: 11705967
• Device Sequence Number: 3998500
• 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): 04/13/2021
• Report Date (Section F): 04/13/2021

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: 04/22/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2021
• 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: 04/13/2021