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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2021

Event Type  malfunction  

Event Description

It was reported that, during an im nailing of proximal femur fracture, four guide pin 3.2mm x 343mm were bending.On obtaining entry point for proximal reamer, guide wires introduced to tip of greater trochanter by hand and bent.Cannulated entry awl was utilised to assist; however, once entry reamer was passed over the guide pin, each guide pin became bent.It is unknown how surgery was completed and how long was delayed as consequence.Patient was not harmed.

Manufacturer Narrative

The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• 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
• MDR Report Key: 11617552
• MDR Text Key: 243901308
• Report Number: 1020279-2021-02710
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00885556158371
• UDI-Public: 00885556158371
• Combination Product (y/n): N
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71631436
• Device Catalogue Number: 71631436
• Device Lot Number: 20JSM0176
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1