MAUDE Adverse Event Report: SMITH & NEPHEW, INC; PIN

Catalog Number 7111-0400

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/07/2014

Event Type  malfunction  

Event Description

The tips of two separate 1.9mm smith and nephew threaded kwires (catalog # 7111-0400) broke off in the patient's right talus.

• Type of Device: PIN
• Manufacturer (Section D): SMITH & NEPHEW, INC; 7000 w william cannon dr.; austin, TX 78735
• MDR Report Key: 4121414
• MDR Text Key: 4950622
• Report Number: 4121414
• Device Sequence Number: 1
• Product Code: HTY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 7111-0400
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2014
• Patient Sequence Number: 1
• Patient Age: 22 YR