MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 11.5MM X 18CM 125D; NAIL, FIXATION, BONE

Catalog Number 71675202

Device Problem Fracture (1260)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Failure of Implant (1924); Arthralgia (2355); Device Embedded In Tissue or Plaque (3165); Implant Pain (4561)

Event Date 01/21/2024

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 experienced a fall with right hip pain.This adverse event was diagnosed by a radiographic imaging that showed the implant failure and a nail broken at proximal screw holes.The x-rays revealed the broken rod as well as a periprosthetic fracture further distal.This adverse event was treated by a revision surgery on (b)(6) 2024, in which a intertan 11.5mm x 18cm 125d was exchanged.It was able to remove the proximal portion of the rod through the tip of the greater trochanter, and the distal portion of the rod through the fracture.The lag and remaining compression screw were left in situ.Then the internal fixation was performed using a plate and cables.Patient's current health status is recovering.

Manufacturer Narrative

H3, h6: the reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the intertan 11.5mm x 18cm 125d.Therefore, no investigation is deemed for the other devices.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that the reported fall cannot be ruled out as a contributing factor to the broken intertan.A persistent periprosthetic fracture may be possible as well as it was not noted if the fracture was the same as previous or a new fracture.The patient impact is the broken lag screw and remaining portion of the compression screw and revision with a plate and cables.Although unlikely, micromotion of the broken implant cannot be ruled out.It was reported the patient was recovering.No further clinical assessment is warranted at this time.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for intramedullary nail system revealed that cracking or fracture of the implant may occur as a possible adverse effect.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, the 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 file 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 this product and event.Per material specification, the quality and manufacture of standard grade titanium, aluminum and vanadium alloy shall be controlled.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include postoperative care, abnormal loading of limb, excessive forces and/or the reported fall.Based on this investigation, the need for corrective action is not indicated.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: INTERTAN 11.5MM 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: 18831724
• MDR Text Key: 336858710
• Report Number: 1020279-2024-00482
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 03596010561053
• UDI-Public: 03596010561053
• 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: 04/10/2024

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: 71675202
• Device Lot Number: 22JSM0137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Date Device Manufactured: 09/18/2022
• 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 100/95, 71677100, 22GT66150.; TRIGEN LOW PROFILE SCREW 5.0MM X 37.5MM, 71645037.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 97 KG