FASTIN RD ANCHOR WITH ETHIBOND *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-06-28 for FASTIN RD ANCHOR WITH ETHIBOND * manufactured by Mitek Worldwide Ethicon, Inc. & Johnson & Johnson.

Event Text Entries

[299268] Additional information received from mfr 11/12/2002: a review of the details of the event shows that no patient injury occurred and that if this were to recur it would not result in serious injury. As a result mitek worldwide is not filing a 3550a report to document the event. This event has been documented in their complaint handling system.
Patient Sequence No: 1, Text Type: D, B5

[17429597] Fastin rc anchor started to bend as surgeon was beginning to insert anchor into bone. Removed before it broke.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1025469
• MDR Report Key: 402965
• Date Received: 2002-06-28
• Date of Report: 2002-06-20
• Date of Event: 2002-06-12
• Date Added to Maude: 2002-07-05
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FASTIN RD ANCHOR WITH ETHIBOND
• Generic Name: *
• Product Code: MBJ
• Date Received: 2002-06-28
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 391975
• Manufacturer: MITEK WORLDWIDE ETHICON, INC. & JOHNSON & JOHNSON
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-06-28