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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2007-05-25 for * manufactured by *.

Event Text Entries

[17676443] The blade and attached shaft (2 cm in length total) was returned for eval. This is the broken piece that was retrieved from the pt. The blade of the shaft shows a lot of striations along the face of the blade; it appears to have been in heavy use. There appears to be gouged metal on the tip and there are some nicks in the metal along the edge of the cutting/blade surface. There is no defect or corrosion visible in the shaft metal at point of breakage. There is no defect trend reported on this device. We believe the condition of this instrument is consistent with damage caused by mechanical overload.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 9610617-2007-00014
• MDR Report Key: 974955
• Report Source: 06,07
• Date Received: 2007-05-25
• Date Added to Maude: 2008-01-08
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 0
• Manufacturer Street: MITTLESTRASSE 8 POSTFACH 230
• Manufacturer City: TUTTLINGEN 78503
• Manufacturer Country: GM
• Manufacturer Postal: 78503
• Manufacturer Phone: **
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: *
• Product Code: EZO
• Date Received: 2007-05-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 943159
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2007-05-25