MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL; NAIL, FIXATION, BONE

Catalog Number UNKNOWN

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Perforation (2001)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case (b)(4).Literature reference: sever gb, cankus mc, karsli b.Comparison of two different proximal femoral nails in instabil intertrochanteric fractures concerning radiological parameters.Ulus travma acil cerrahi derg.2021 may;27(3):344-350.English.Doi: 10.14744/tjtes.2020.41343.Pmid: 33884599.

Event Description

It was reported that on literature review "comparison of two different proximal femoral nails in instabil intertrochanteric fractures concerning radiological parameters", one (1) patient suffered from varus collapse, cut-out and tip apex distance (tad) of 52 mm after an intertrochanteric fracture treatment with an intertan intertrochanteric antegrade nail.The event was treated with a secondary surgery (partial endoprosthesis).The outcome of the patient is unknown.No further information is available.

Manufacturer Narrative

The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the literature article was reviewed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should additional medical information be provided this complaint will be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance, traumatic injury, patient anatomy or abnormal loading of limb the contribution of the device to the reported event could not be corroborated.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: UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL
• 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: 14249530
• MDR Text Key: 290368339
• Report Number: 1020279-2022-02053
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2022
• 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
• Patient Outcome(s): Other; Hospitalization; Required Intervention