MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INT HEX CAP SCR 5.0MM X 40MM; TITANIUM NAIL SYSTEM

Catalog Number 71642240

Device Problems Failure To Adhere Or Bond (1031); Break (1069)

Patient Problem No Code Available (3191)

Event Date 05/14/2015

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to a broken screw and non-union.

Manufacturer Narrative

Analysis concluded that the 5.0 × 40 mm trigen internal hex captured screw likely fractured due to a fatigue crack initiation and propagation.The lot/batch numbers could not be identified.Damage to the screw threads was observed near the fracture initiation site.The fatigue crack eventually propagated to an extent that the remaining cross-sectional area of the screw could not bear the imposed patient loading, which led to an overload fracture of the screw.Fatigue fracture is caused by the screw bearing cyclic (i.E., repeated) stresses in excess of the material endurance limit for an extended period of time.These excessive cyclic stresses may be caused by any number of conditions, including, but not limited to, excessive patient activity levels prior to full bone union, applications of loads in excess of the material¿s strength, and/or poor bone quality.No material deviations in the screw were found during this investigation.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This investigation could not verify or identify any evidence of product contribution to the reported problem.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: INT HEX CAP SCR 5.0MM X 40MM
• Type of Device: TITANIUM NAIL SYSTEM
• 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: robert rust ; 1450 brooks road; memphis, TN 38116 ; 9013991624
• MDR Report Key: 4915442
• MDR Text Key: 15585576
• Report Number: 1020279-2015-00462
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71642240
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 48 YR
• Patient Weight: 90