MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 80MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71645080

Device Problems Migration or Expulsion of Device (1395); Device Slipped (1584)

Patient Problems Injury (2348); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported a revision surgery was performed due to a trigen hfn calc-cuboid screw that had backed out.

Manufacturer Narrative

The associated complaint devices were not returned for evaluation.Please see attached for investigation results.(b)(4).

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 80MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: claudia de santis ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 6444473
• MDR Text Key: 71204202
• Report Number: 1020279-2017-00230
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71645080
• Device Lot Number: 16ET69354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2016
• 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): Hospitalization; Required Intervention