MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 10MMX34CM 125D RT; NAIL, FIXATION, BONE

Model Number 71676510

Device Problem Fracture (1260)

Patient Problem Hip Fracture (2349)

Event Date 08/25/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, after an internal fixation surgery performed on (b)(6) 2020, patient underwent a revision surgery on (b)(6) 2022 due to a fracture in the femur with no history of significant trauma, and a fracture of the intertan 1.5 10mm x 34cm 125d right, as well.Current health status of the patient is unknown.

Manufacturer Narrative

The device was not returned for evaluation.A x-ray photo was provided which shows a break in the femoral nail which supports the complaint.The clinical/medical investigation.Concluded that, without comparison images we cannot conclude if the fracture in the provided image is a continuation of the previous fracture that was reported as healed.The clinical root cause of the reported fracture cannot be definitively determined based on the information provided.Although we cannot rule out a trauma as a likely contributory factor or continuation of previous fracture is possible even though it was reported as ¿healed¿.Therefore, it cannot be concluded that the reported events were associated with a mal performance of the implant 2 years later.Since the current health status of the patient is unknown, the impact to the patient beyond the reported fracture, revision and subsequent post-operative convalescent period cannot be determined.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 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 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include patient bone quality, post-operative patient condition, abnormal loading of limb.The contribution of the device to the reported incident could be corroborated as the device was broken and it was required a revision surgery.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: INTERTAN 1.5 10MMX34CM 125D RT
• 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: 15466673
• MDR Text Key: 300401149
• Report Number: 1020279-2022-04154
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 00885556039601
• UDI-Public: 00885556039601
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K040212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71676510
• Device Catalogue Number: 71676510
• Device Lot Number: 13JM16852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 10/20/2022
• Supplement Dates FDA Received: 10/21/2022
• Date Device Manufactured: 05/25/2019
• 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, LOT#:19GM20866; TRIGEN LOW PROFILE SCREW 5.0MM X 35MM, LOT#:20CM19; TRIGEN LOW PROFILE SCREW 5.0MM X 45MM, LOT#:20AM26
• Patient Outcome(s): Hospitalization; Required Intervention