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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 08 report with the FDA on 2006-11-07 for * manufactured by *.

Event Text Entries

[8054838] Results: the instrument in question was manufactured in a lot of 25 pcs in 2005 and delivered to the distributor the same day. Based on our trend analysis records, which allow us to trace back to january 2003, we have never received a complaint of this nature. A thorough review of our production records confirms that the right materials had been used and that the instruments had been manufactured according to design (master sample) and productions specifications received from the distributor. As part of the investigation we also performed is a hardening test. The hardening protocol shows the measured hardness of 54,8 hrc (average value) is within the range of tolerance of hrc 48 - 56. Conclusion: no definite conclusion, for the exact cause of this break can be drawn. Based on our longterm experience as qualified surgical instrument mfr, we are of the opinion that, the occurrence of a break in this area during surgical application can be excluded. However, it is within the realm of possibility that the cup could break off during the cleaning and sterilization process, for instance, when the instrument tip gets caught in or is picked up uncautiously from the sterilization tray. As stated above, our production records indicate compliance with all specifications and our trend analysis reflects no problem with this pattern. Thus, we feel that no corrective or preventive action is required on our part.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 9611112-2006-00004
• MDR Report Key: 787370
• Report Source: 08
• Date Received: 2006-11-07
• Date Mfgr Received: 2006-10-18
• Device Manufacturer Date: 2005-07-01
• Date Added to Maude: 2006-11-29
• 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: 3
• Event Location: 0
• Manufacturer Street: BADSTRASSE 8
• Manufacturer City: TUTTLINGEN 78532
• Manufacturer Country: GM
• Manufacturer Postal: 78532
• Manufacturer Phone: 46194710
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: RL
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: *
• Product Code: JYG
• Date Received: 2006-11-07
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 775137
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-11-07