MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 55MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71645055

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Bacterial Infection (1735)

Event Date 04/07/2021

Event Type  Injury  

Event Description

It was reported that, due to a fall on (b)(6) 2020, a patient experienced a right tibial fracture which required a temporary treatment with an external fixator on (b)(6) 2020. This external fixator was removed on (b)(6) 2020 and after a right tibial internal infixation surgery with trigen low profile screw 5. 0mm x 35mm performed the same day, the patient experienced secretion and wound healing problems with the presence of staphylococcus aureus. A revision surgery was performed on (b)(6) 2021 to treat this adverse event. The trigen low profile screw 5. 0mm x 35mm (x2), int hex cap scr 5. 0mm x 35mm, trigen low profile screw 5. 0mm x 40mm and trigen low profile screw 5. 0mm x 55mm were explanted during this revision surgery. It is unknown if the explanted device was substituted with a smith and nephew implant. The patient outcome is unknow.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 55MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 11817087
• MDR Text Key: 250361161
• Report Number: 1020279-2021-04180
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 71645055
• Device Catalogue Number: 71645055
• Device Lot Number: 19GM06120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/13/2021 Patient Sequence Number: 1