MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE PIN 3.2MM X 343MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71631436

Device Problem Material Twisted/Bent (2981)

Patient Problem Perforation (2001)

Event Date 05/31/2021

Event Type  Injury  

Event Description

It was reported that during trauma surgery, after inserting the guide pin 3. 2 mm x 343 mm for an intertan nail, the surgeon noticed that the guide pin was bent. The physician inserted another guide pin 3. 2 mm x 343 mm which also bent. There were extra pin holes in the femoral head as a result of the pins bending and the surgeon had to accommodate for the bending guide wires, the holes were not treated. A smith and nephew back up device was available. No delay reported. The patient's outcome is unknown. No further information is available.

• Brand Name: GUIDE PIN 3.2MM X 343MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 12011194
• MDR Text Key: 256561348
• Report Number: 1020279-2021-05195
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/01/2021

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

• Device Model Number: 71631436
• Device Catalogue Number: 71631436
• Device Lot Number: 21ASM0351
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/16/2021 Patient Sequence Number: 1