MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 18CM 130D; NAIL, FIXATION, BONE

Catalog Number	71675384
Medical Device Problem Codes	Failure to Align (2522); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates 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.
Event or Problem Description
It was reported that, during an internal fixation surgery, one (1) intertan 10s 10mm x 18cm 130d as opened and inserted successfully.However, during the locking phase, the leg screw repeatedly hit the reported device, causing bending and stripping.The reported device was removed and tested outside the patient with the screws and anti rotation sleeve.Although it appeared functional externally, the screw continued to hit the reported device.The implant was then changed to a 125 degree, 10 mm × 18 cm nail, after which the procedure was completed successfully without further complications.The procedure was resumed, after a significant delay, using a similar s+n back up.The procedure required additional anesthesia.No further complications were reported.
Additional Manufacturer Narrative
H6, h11: the device was not returned for evaluation; therefore, a device analysis could not be performed.However, the clinical/medical investigation concluded that, the fluoroscopic images appear to show the targeting in the most superior aspect of the proximal lag screw hole as well the introduction angle doesn¿t appear consistent with the lag screw hole which would support the complaint.The explanted nail shows scratches/deformation of the proximal lag screw hole likely from attempted lag screw targeting/implantation, as well as the proximal nail end, likely due to extraction.The instructions for use for trigen¿ intertan¿ nail system reveals that it is the healthcare professional¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device proper surgical technique and implant selection are essential to a successful outcome.The surgical technique includes specific recommendations from assembly to implantation and notes to confirm the nail and drill guide handle are securely connected after definitively seating the nail as hammering can loosen the guide bolt.Nail assembly notes that an incorrectly attached nail will not target.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 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 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 surgical technique used, size selected or user/procedural variance.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 10S 10MM X 18CM 130D
• 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: 24177296
• Report Number: 1020279-2026-00100
• Device Sequence Number: 10065711
• Product Code: JDS
• UDI-Device Identifier: 00885556105740
• UDI-Public: 885556105740
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K241804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71675384
• Device Lot Number: 25EM09315
• 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: 01/02/2026
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2025
• 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
• Patient Sex: Unknown