MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.7/3.5 M-D TIBIA PL 9H L 130MM; PLATE, FIXATION, BONE

Model Number	72463909
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, at the time of opening the evos 2.7/3.5 mm medial distal tibia.Envelope, the sterile package was damaged.It seems that it was not blistered.The surgeon decided to use the item, therefore, only the product package will be sent for further investigation.No injuries or surgical delays were reported.Backup device information was not initially provided.

• Brand Name: EVOS 2.7/3.5 M-D TIBIA PL 9H L 130MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038246
• MDR Report Key: 9833781
• Report Number: 1020279-2020-00861
• Device Sequence Number: 11545735
• Product Code: HRS
• UDI-Device Identifier: 00885556640838
• UDI-Public: 00885556640838
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K170457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 72463909
• Device Catalogue Number: 72463909
• Device Lot Number: 19BM03323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 10/04/2021; 11/19/2021
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 10/05/2021; 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown