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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 005 10 13 000
Date submitted: 10/1/2013
Device Type:Bone rasp , optimys Opening Broach bent
Description:Orthopaedic surgery tools , Bone rasp , optimys Opening Broach bent
Medical Device Identifier:Article number: 51.34.0079 Lot numbers: 6053731, 6054883, 6057918, 6059150, 6060683
Reason of Field Safety Corrective Action:Mathys Ltd Bettlach (Mathys) has been notified of an incident in where the optimys Opening Broach broke intraoperatively and the fragment was left in the bone. Investigations have shown that the instrument was not used in compliance with the instructions, and detailed exploration revealed that this was causal to the incident. In the course of the investigations, it became apparent that the Opening Broach bent may exhibit surface defects in the hewn portion which may favor breakage in case of non-compliant usage
Remedy Action:Please read this Field Safety Notice carefully. And replacement products made of material more suitable for the field of application are currently being manufactured. As soon as they become available ,manufacture will inform you and arrange for the replacement at your hospital.
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:CH-2013-09-26-082
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Vk_20130925_22-e1.pdf