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

Catalog Number UNKN02100103

Device Problem Migration (4003)

Patient Problem Hip Fracture (2349)

Event Date 05/30/2021

Event Type  Injury  

Event Description

It was reported that, during intramedullary nailing fixation of an intertrochanteric hip fracture, a total of 5 guide pin 3.2 mm x 343 mm were noticed to be too soft and deformable.This issue, confirmed by x-rays when the anti-rotation bar was inserted and was noticed to be contacting the tip of the guide pin in the femoral head, led to the intramedullary nail migrating proximally and the guide pin bending during drilling with the compression starter drill and later on with the compression drill.Because of this, it was necessary to remove and reposition both the lag and compression screws.A surgical delay of less than 30 minutes occurred due to this event, but it is unknown if the procedure was concluded with the same guide pins or with backup guide pins.No other complications were reported.

Manufacturer Narrative

H10: after further assessment of the events referenced in this case, it was determined that the sixth complaint (b)(4) , currently raised as a complaint against the femoral nail, should be considerer as a concomitant product rather than a valid complaint.The rationale behind this decision is that, although it was originally reported that the nail migrated proximally, this could be considered as a direct consequence of the x5 guide pin 3.2mm x 343mm (b)(4) been deformable and soft.Without a proper guide provided by these pins, it is expected that the nail might migrate from its original position, while drilling with compression starter drill and compression drill the holes intended for the compression and lag screws insertion.As this issue was solved by re-drilling and re-positioning of both lag and compression screw, a complaint should not be raised against neither the femoral nail nor the lag and compression screw implanted to treat this intertrochanteric fracture.

• 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
• MDR Report Key: 12010912
• MDR Text Key: 256558334
• Report Number: 1020279-2021-05186
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN02100103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention