WIRE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-02-24 for WIRE manufactured by Synthes (usa).

Event Text Entries

[2629062] After a heart procedure the patient was closed with (2) wires in the manubrium, (3) sternal zipfix with needle on the sternum, and a wire at the zyphoid. On a follow-up scan the sternum had "shifted up". Reportedly the sternum has healed in an improper position. The surgeon has no plans to re-open the patient at this time. This report is #6 of 6 for the same event.
Patient Sequence No: 1, Text Type: D, B5

[9758254] Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2520274-2012-00290
• MDR Report Key: 2488226
• Report Source: 05,07
• Date Received: 2012-02-24
• Date of Report: 2012-02-01
• Date Mfgr Received: 2012-02-01
• Date Added to Maude: 2012-08-23
• 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: 0
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: J. TEMPLE
• Manufacturer Street: 1302 WRIGHTS LANE E.
• Manufacturer City: WEST CHESTER PA 19380
• Manufacturer Country: US
• Manufacturer Postal: 19380
• Manufacturer Phone: 8006207025
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: WIRE
• Generic Name: WIRE
• Product Code: HXS
• Date Received: 2012-02-24
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SYNTHES (USA)
• Manufacturer Address: WEST CHESTER PA US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-02-24