MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.0MM X 12MM LCK SCR T6 S-T PLATE, FIXATION, BONE

Model Number 72412012N

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Date 06/03/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Event Description

It was reported that after a wrist surgery performed on (b)(6) 2022 one of the evos 2. 0mm x 12mm lck scr t6 s-t broke with just hand twisting. A revision surgery was performed on (b)(6) 2022 to solve the issue. Further information is unknown at the moment.

• Brand Name: EVOS 2.0MM X 12MM LCK SCR T6 S-T
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14843049
• Report Number: 1020279-2022-03136
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556443644
• UDI-Public: 00885556443644
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K140814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 72412012N
• Device Catalogue Number: 72412012N
• Device Lot Number: 21DM11079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Outcome(s): Hospitalization; Required Intervention