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

Catalog Number 71675383

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2024

Event Type  Injury  

Manufacturer Narrative

H3, h6: (b)(4).

Event Description

It was reported that, after an internal fixation surgery had been performed on unknown date, the intertan had failed.This adverse event was solved by revision surgery on (b)(6) 2024, in which one (1) intertan 10s 10mm x 18cm 125d; two (2) lag/comp screw kit 95/90 and one (1) trigen low profile screw 5.0mm x 35mm were explanted.Current health status of patient is fine.No further complications were reported.

Manufacturer Narrative

D4: lot# and expiration date, h4: device manufacture date and h6: medical device problem code.Section h3, h6: the associated devices were returned and evaluated.The visual inspection revealed multiple scratches and discoloration on the explant.The visual of the screws returned also reveal signs of wear.Our quality engineering team concluded that, due to damage incurred during extraction, the product could not be dimensionally evaluated.The clinical/medical investigation concluded that, per the complaint, after an internal fixation surgery was performed on an unknown date, the intertan had failed.The report stated that this adverse event was solved by revision surgery on 19-jan-2024.An x-ray image was provided on a operation room computer which shows the backing out of the compression screw.According to the report, the surgeon explanted one (1) intertan 10s 10mm x 18cm 125d; two (2) lag/comp screw kit 95/90 and one (1) trigen low profile screw 5.0mm x 35mm.No further complications were reported.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.A review of the instructions for use documents for intramedullary nail system revealed that care prior to bony union stablish to immobilize and/or externally support skeletal structures that have been implanted with surgical metallic implants until skeletal union is observed.Early weight bearing substantially increases implant loading and increases the risk of loosening, bending or breaking the device.Early weight bearing should only be considered where there are stable fractures with good bone-to-bone contact.Patients who are obese and/or noncompliant, as well as patients who could be pre-disposed to delayed or non-union, should have auxiliary support.The implant may be exchanged for a larger, stronger nail subsequent to the management of soft tissue injuries.Patients and nursing care providers should be advertised of these risks.For the nail, a review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the screws, device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.For the nail, 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.For the screws, a review of complaint history for the previous 12 months did not reveal similar events for the listed devices.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.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.However, based on the information provided, the unsatisfactory experience could be confirmed.Factors that could contribute to the reported event include abnormal loading of limb, alignment, size selected, patient anatomy, procedural/user error 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.H6: health effect - clinical code.

• 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: 18694491
• MDR Text Key: 335244157
• Report Number: 1020279-2024-00354
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 71675383
• Device Lot Number: 23DM02636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2023
• 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
• Treatment: 71645035 / TRIGEN LOW PROFILE SCREW 5.0MM X 35MM.; 71677095 / LAG/COMP SCREW KIT 95/90.; 71677095 / LAG/COMP SCREW KIT 95/90.
• Patient Outcome(s): Hospitalization; Required Intervention