MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 42.5MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71645042

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Unequal Limb Length (4534)

Event Date 07/05/2021

Event Type  Injury  

Event Description

It was reported that, after an open reduction with osteosynthesis had been performed on (b)(6) 2018 to treat an intertrochanteric femoral neck multifracture, the patient experienced pseudoarthrosis with a nonunion of the treated femoral fracture, a right leg length discrepancy, anteflexion deformity and the fracture of the intertan 11. 5mm x 38cm 125d rt along with the breakage of a proximal screw. A revision surgery was performed on (b)(6) 2021 to treat this adverse event. During this procedure, the nail and screws were removed, and a hip joint replacement construct was implanted. The patient¿s outcome is unknown.

Manufacturer Narrative

Internal complaint reference (b)(4).

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 42.5MM
• 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: 13011240
• MDR Text Key: 282279639
• Report Number: 1020279-2021-08681
• 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: Other,Foreign,Health Professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 71645042
• Device Catalogue Number: 71645042
• Device Lot Number: 15FT55116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage