K-WIRES 71161012

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-08-22 for K-WIRES 71161012 manufactured by Smith & Nephew, Inc.

Event Text Entries

[3708081] Revision surgery was reported due to a broken k-wire in the distal humerus.
Patient Sequence No: 1, Text Type: D, B5

[11063938] .
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1020279-2013-00417
• MDR Report Key: 3303349
• Report Source: 01,07
• Date Received: 2013-08-22
• Date of Report: 2013-07-05
• Date of Event: 2013-07-03
• Date Mfgr Received: 2013-07-05
• Device Manufacturer Date: 2012-05-07
• Date Added to Maude: 2013-08-22
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: MS. CARLA SAMUELS
• Manufacturer Street: 1450 BROOKS ROAD
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal: 38116
• Manufacturer Phone: 9013995076
• Manufacturer G1: SMITH & NEPHEW, INC.
• Manufacturer Street: 1450 BROOKS ROAD
• Manufacturer City: MEMPHIS TN 38116
• Manufacturer Country: US
• Manufacturer Postal Code: 38116
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: K-WIRES
• Generic Name: PERI-LOC K-WIRE 1.25MM
• Product Code: DZK
• Date Received: 2013-08-22
• Catalog Number: 71161012
• Lot Number: 12EM04034
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SMITH & NEPHEW, INC
• Manufacturer Address: 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2013-08-22