MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 45MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71645045

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Necrosis (1971); Pain (1994); Non-union Bone Fracture (2369)

Event Date 03/07/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that after a trigen intertan system was implanted on plaintiff left femur on (b)(6) 2018, the plaintiff experienced increased pain on left knee. By x-rays, failure of the distal locking screws and distal migration of the tip of the nail were found. A revision surgery was performed on (b)(6) 2019 to treat these adverse events. During surgery, it was found that the proximal ends of 2 distal locking screws were broken. The trigen intertan components were explanted. The patient outcome is unknown.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 45MM
• 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: 12523528
• Report Number: 1020279-2021-07100
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00885556215890
• UDI-Public: 00885556215890
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 71645045
• Device Catalogue Number: 71645045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: KG
• Patient Outcome(s): Hospitalization; Required Intervention