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

Catalog Number UNKNOWN

Device Problem Fracture (1260)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference (b)(4).

Event Description

It was reported that, after an intertan internal fixation performed on an unspecified date, it was noticed that the patient had the intertan nail broken.The surgeon believes the patient fell at home.It is unknown how this adverse event was treated.

Manufacturer Narrative

H3, h6: given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the patient had the intertan nail broken as well as an intertrochanteric fracture of the femur at the level of the broken nail, as seen on the x-ray.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, risk management file, prior actions and product prints review could not be performed.However, a review of the instructions for use for intramedullary nails systems revealed that cracking or fracture of the implant may occur.Preoperative planning section states that proper type and size of implant must be selected to ensure effective treatment of patients considering factors such as patient¿s size, strength, skeletal characteristics, skeletal health, and general health.Overweight or musculoskeletal deficient or unhealthy patients may create greater loads on implants that may lead to breakage or other failure of the implants.Additionally, postoperative care section warns that early weight bearing substantially increases implant loading and increases the risk of breaking the device.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include patient anatomy, abnormal loading of limb, excessive forces and/or traumatic injury.Based on this investigation, the need for corrective action is not indicated.Should 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: UNKNOWN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL IMPLANT
• 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: 18242226
• MDR Text Key: 329430917
• Report Number: 1020279-2023-02370
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2023
• 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): Required Intervention