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	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During procedure, 1" of a 2.5 drillbit broke in the bone.Fragment was unable to be removed.Clinical decision was made that the risks of removing the fragment outweighed the benefits of removing.

• Brand Name: EVOS
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 13901013
• Report Number: 13901013
• Device Sequence Number: 4596288
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/15/2022
• Report Date (Section F): 03/15/2022

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
• Operator of Device: Health Professional
• Device Model Number: 71175022
• Device Catalogue Number: 71175022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 78 KG
• Date Report Sent to FDA: 03/15/2022