MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL; NAIL, FIXATION, BONE

Catalog Number UNKNOWN

Device Problem Malposition of Device (2616)

Patient Problems Bone Fracture(s) (1870); Loss of Range of Motion (2032)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Georgiadis, g.M., stein, c.M., bair, j.M., tank, j.C., georgiadis, a.G., & redfern, r.E.(2019).Sagittal plane considerations during long cephalomedullary nailing: optimal distal positioning and the role of intraoperative nail bending.Journal of orthopaedic trauma, 33(11), 553-558.Doi: 10.1097/bot.0000000000001577.

Event Description

It was reported that on literature review "sagittal plane considerations during long cephalomedullary nailing: optimal distal positioning and the role of intraoperative nail bending", 1 patient with anterior cortical contact (acc) suffered from late supracondylar fracture at the distal end of the nail, after having an internal fixation surgery with the trigen intertan system.This fracture occurred 6 months after the primary nailing procedure and was treated with internal fixation using a lateral locking plate.The outcome of the patient is unknown.No further information is available.

Manufacturer Narrative

H3, h6.The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the article noted 1 patient with anterior cortical contact (acc) experienced a late supracondylar fracture at the distal end of the nail approximately 6 months post cm nailing and was treated with internal fixation using a lateral locking plate.Two x-rays from the supplemental link were reviewed; however, unable to definitively conclude the root cause of the fracture.Further patient specific supporting documentation has not been provided as of the date of this medical investigation.The clinical root cause of the reported acc/impingement, late fracture, and subsequent plating cannot not be further assessed.The patient¿s outcome beyond that which was documented in the article cannot not be determined as the patient¿s current health status remains unknown.No further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant, traumatic injury and surgical technique.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL
• Type of Device: NAIL, 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: 14283385
• MDR Text Key: 290770610
• Report Number: 1020279-2022-02150
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other