MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 11.5MM X 38CM 130D LT; NAIL, FIXATION, BONE

Catalog Number	71675291
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after an internal fixation surgery had been performed in 2023, the patient experienced gradually development of pain.The compression screws of the intertan 11.5mm x 38cm 130d lt were protruding, causing discomfort and pain.It was found that the top section of one (1) intertan 11.5mm x 38cm 130d lt broke, leaving distal nail section, and there was non-union of the fracture.This adverse event was treated by a revision surgery on (b)(6) 2026, in which the intertan 11.5mm x 38cm 130d lt was explanted.Femoral shaft window was made to mallet nail out of patient.Indentations were made on anterior side to be able to mallet nail out.The current health status of the patient is good.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication related to a product problem.With a smith+nephew device.The reported issue(s) relate to known risks with the device itself or with its use that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).Additional information: d9, e1, h3, h6, and h11.H11: the associated device was returned and evaluated.The visual inspection revealed that the device returned with the proximal end fractured off, wear from use and extensive damage from removal.The clinical/medical investigation concluded that, without comparison imaging, it cannot be determined whether adequate fixation was achieved during the primary surgery.A fatigue fracture of the intertan nail due to prolonged cyclic loading in the setting of a chronic non-union remains a likely mechanism, with the implant acting as the primary load-bearing structure during ambulation.Contributing factors are multifactorial and could include possible non-union of the fracture 3 years later, patient-specific limitations in healing (advanced age, low body weight, skeletal health), extended implant duration (~2.5¿3 years) and/or continued walking generating repetitive mechanical stress.The timing between the initial radiographic of the nail fracture and the scheduled revision, as well as the patient¿s continued ambulation on the broken implant, may also have contributed to pain and discomfort.It remains unclear whether the instructions for use for the trigen intertan nail system was fully adhered to, and based on the available information, these events cannot be concluded to represent device malperformance or implant failure.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 trigen intertan nail system revealed in preoperative revealed that the following factors should be considered: a 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 and whether a patient has a degenerative or progressive disease that delays or prevents healing and consequently decreases the effective life of the implant.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.According with inspection drawing, the final inspection includes the verification of part configuration per print.Also, per material specification, 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 product failed to meet any specifications at the time of manufacture.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.

• Brand Name: INTERTAN 11.5MM X 38CM 130D LT
• Common Device Name: 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 24310290
• Report Number: 1020279-2026-00193
• Device Sequence Number: 20253112
• Product Code: JDS
• UDI-Device Identifier: 03596010561008
• UDI-Public: 3596010561008
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71675291
• Device Lot Number: 22KSM0118
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 47 KG