MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 40CM 125D LEFT; NAIL, FIXATION, BONE

Catalog Number	71675515
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after an internal fixation surgery had been performed on an unknown date, the patient experienced pain.This adverse event was solved by a revision surgery on (b)(6) 2025, in which one (1) intertan 10s 10mm x 40cm 125d left and one (1) lag/comp screw kit 90/85 were removed, as the patient¿s anatomy required a neck angle greater than 125 degrees.These were replaced with a competitor device.The back-up device was implanted into the originally drilled bone hole.Current health status of patient remains unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent procedural risks 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 confirm a relationship between the reported event and the device or 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
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation revealed that, as of the date of this investigation, no additional supporting documentation has been received or made available for review.Per subsequent e-mail, this 76-year-old female with osteoporotic bone was "implanted with a 125-degree nail that was not suited to the patient¿s anatomy." therefore, a procedural variance vs user error could not be ruled out as the likely cause of the reported pain.The instructions for use for intramedullary nail system does warn, ¿that correct surgical technique is essential to a successful outcome.Proper reduction of fractures and proper placement of implants are necessary to effectively treat patients using metallic surgical implants.Additionally, the proper type and size of implant must be selected to ensure effective treatment of patients.¿ according to the report, a revision surgery was performed to resolve this adverse event using a competitor¿s device in the original bone hole.The impact to the patient beyond the pain, revision and the use of the competitor¿s device could not be determined, since the current health status of patient remains unknown.The devices' batch numbers were not provided; thus, an evaluation of the manufacturing records could not be performed.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.Based on this investigation, the need for corrective action is not indicated.Should the devices 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 40CM 125D LEFT
• 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: 22203122
• Report Number: 1020279-2025-01069
• Device Sequence Number: 7714562
• Product Code: JDS
• UDI-Device Identifier: 00885556344446
• UDI-Public: 885556344446
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71675515
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71677090 / LOT: UNKNOWN.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Female