MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INT HEX CAP SCR 5.0MM X 45MM; TITANIUM NAIL SYSTEM

Catalog Number 71642245

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 09/02/2014

Event Type  Injury  

Event Description

It was reported that there was a revision of locking screws.

Manufacturer Narrative

Customer indicated that there is no product/device to be returned for investigation analysis.A review of the device history records and quality records associated with this manufactured lot confirmed that no abnormalities were reported with this product during manufacture.

• Brand Name: INT HEX CAP SCR 5.0MM X 45MM
• 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: lisa hassell ; 1450 brooks road; memphis, TN 38116 ; 9013991128
• MDR Report Key: 4242700
• MDR Text Key: 5065497
• Report Number: 1020279-2014-00687
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K981529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2023
• Device Catalogue Number: 71642245
• Device Lot Number: 13DM06120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/06/2014
• Initial Date FDA Received: 11/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2015
• Date Device Manufactured: 04/09/2013
• 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
• Treatment: (B)(4) - LOT# 13DT2981
• Patient Outcome(s): Required Intervention