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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 096 07 12 000
Date submitted: 7/29/2012
Manufacturer:Zimmer inc
Device Type:Fixation system, Internal orthopaedic fixation system, plate/screw
Description:Non-biodegradable, self taping screws
Medical Device Identifier: NCB screws 4.0 self taping screws; Model number: 02.03155.032 (32 mm); 02.03155.026 (26 mm) Lot/batch no.: 2649944 (32 mm), 2649941 (26 mm)
Reason of Field Safety Corrective Action:The issue concerns a mix up of two lots of NCB Screws with different lengths but the same diameter (4mm). NCB Screws with a length of 26mm were placed in the 32 mm packaging and vice versa. These trauma screws are delivered non sterile and are placed in the implant rack and sterilized before use. As a general practice, screw length is checked before placing the screw into the right place of the implant rack (figure 1). This is done using a template which is incorporated into the rack itself. During the surgery, when picking a screw, the nurse checks the length of screw once again using the same template.
Remedy Action: The affected lengths 26 and 32 mm of these NCB screws (diameter 4 mm) which are still in consignment as unopened must be removed from the clinics and returned to Zimmer GmbH for scrapping. Remaining parts of the two affected lots in ownership of Zimmer (in Zimmer inventories) will be scrapped as well. Immediate corrective action: A CAPA has been concluded which changes the production process and inspection of the non sterile screws as follows: - Additional manual control of the screw length for non sterile screws with length template before further processing of the screws (1 screw per section). - Introduction of bar code identification for non sterile screws - individual transport box per lot
Athorized Representative/Importer/Distributor:Ebrahim M. Al-Mana & Bros. Co. Ltd., Riyadh, (01) 4610733
Report Source:NCAR
Source Ref. Number:CH-2012-07-17-038
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments