MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 18CM 125D; NAIL, FIXATION, BONE

Catalog Number 71675383

Device Problem Fracture (1260)

Patient Problems Fall (1848); Failure of Implant (1924); Implant Pain (4561)

Event Date 02/04/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, after a orif surgery was performed on (b)(6) 2023, the patient presented to the ed on (b)(6) 2024, reported a fall on (b)(6) 2024 with continued right hip pain.This adverse event was diagnosed, on (b)(6) 2024, by a radiographic imaging that showed the implant failure and a fracture.The x-rays revealed the rod broken proximally through the screw holes, and the compression screw was broken at the medial border of the rod.The patient declines a revision surgery and it seems to be healing in a varus malunion with a limp and leg length discrepancy.Patient's current health status is unknown.

Manufacturer Narrative

H3, h6: given the nature of the alleged incident, the devices could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the provided x-ray was reviewed and corresponds with the reported broken rod proximally through the screw holes and the broken compression screw at the medial border of the rod.There is also some radiolucency around the nail so there may have been micromotion, but this cannot be confirmed with the single image.There is also a femoral intertrochanteric fracture but with no comparison cannot conclude if this is a new or persistent fracture which was treated in 2023.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.The reported fall or possible persistent intertrochanteric fracture with fatigue stress on the nail cannot be ruled out as a contributing factor to the broken intertan.The patient impact is the broken intertan, healing in a varus malunion with a limp and leg length discrepancy.No further clinical assessment is warranted at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the rod, a review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.For the compression screw, a review of complaint history revealed a similar event for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for intramedullary nail system revealed in possible adverse effects 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.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.According with the inspection drawings, the final inspection includes the verification of part configuration per print.Also, per material specifications, the quality and manufacture of standard grade titanium-6 aluminum-4 vanadium alloy shall be controlled.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, surgical technique, postoperative care, 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: INTERTAN 10S 10MM X 18CM 125D
• 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: 18831529
• MDR Text Key: 336859187
• Report Number: 1020279-2024-00480
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 00885556105696
• UDI-Public: 00885556105696
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040212
• 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: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71675383
• Device Lot Number: 22KM02565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Date Device Manufactured: 10/05/2022
• 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
• Treatment: LAG/COMP SCREW KIT 90/85, 71677090, 22HM12161.
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 59 KG