Kiri

<?xml version="1.0" encoding="UTF-8"?> <fsca xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" version="V2.7 2012-12-03" xsi:noNamespaceSchemaLocation="FSCA_Final_v2.6.xsd"> <summary> <ncaName>Republic of Estonia Health Board</ncaName> <reportType>Final</reportType> <reportDate>2025-08-08</reportDate> <mfrInternalNo>ZFA-2024-00248</mfrInternalNo> <ncaReportNo>Not provided</ncaReportNo> <ncaCoordinating>See section 8 Comments, point 1.</ncaCoordinating> </summary> <contact_info> <reporterOther> <statusReporter>Others</statusReporter> <reporterOtherText>See section 8 Comments, point 1.</reporterOtherText> <ncpDetails> <ncpName>Zimmer Lebanon GmbH</ncpName> <ncpContactPerson>Rana Al Baaklini</ncpContactPerson> <ncpAddress>Qubic Square Business Center Office 6C</ncpAddress> <ncpCity>Beirut</ncpCity> <ncpCountry>NL</ncpCountry> <ncpPostcode>N/A</ncpPostcode> <ncpPhone>+96181477593</ncpPhone> <ncpEmail>[email protected]</ncpEmail> </ncpDetails> <mfrDetails> <mfrName>Biomet France</mfrName> <mfrContactName>Yannick Bossert</mfrContactName> <mfrAddress>Plateau de Lautagne cedex 9</mfrAddress> <mfrCity>Valence</mfrCity> <mfrCountry>FR</mfrCountry> <mfrPostcode>26903</mfrPostcode> <mfrPhone>+33675227628</mfrPhone> <mfrEmailAddress>[email protected]</mfrEmailAddress> </mfrDetails> <arDetails> <ARCountry>FR</ARCountry> </arDetails> </reporterOther> </contact_info> <deviceDetails> <deviceClass>MDD Class III</deviceClass> <nomenclatureSystem>GMDN</nomenclatureSystem> <nomenclatureCode>46059</nomenclatureCode> <nomenclatureCodeDefinedInText>Orthopaedic cement, antimicrobial</nomenclatureCodeDefinedInText> <brandName>Optipac® Vacuum mixing system</brandName> <modelNum>See Field Safety Notice(s), attachment 2 "Affected Product List".</modelNum> <nbIdNum>0123</nbIdNum> </deviceDetails> <fscaDesc> <fscaBackground>Biomet France is conducting a medical device Field Safety Corrective Action (correction) for certain Optipac products due to an increased number of product complaints where it was reported that during the process of preparation, the monomer liquid does not enter into the cylinder once the blue monomer holders are pushed towards the middle of the cylinder. To date, no adverse events have been reported. Following investigation, the issue can be linked to an incomplete tightening of the mixing rod when it is assembled with the cylinder during use. It can lead to an incomplete vacuum within the system, which can prevent the complete release of the monomer in the cylinder. The product cannot be used when the monomer liquid has not entered the cylinder, and it must be discarded after such occurrence.</fscaBackground> <fscaDescription>Zimmer Biomet determined that the most appropriate action is to inform affected customers on the correct assembling instructions without product removal. CAPA Reference Number: CA-07416 Current Phase: Verification of Effectiveness Root Causes: 1) Incorrect assembly performed by users between the Top and the Cylinder. The IFU is not precise enough on what is a correct tightening of the system and there is no information on how to inspect that correct tightening. 2) During CC2021-0014, the drawing was remediated but no cylindricity requirement was featured, and lack of precision in regard to thread core led to impact on tightening related features (torque increase). Corrective and Preventive Actions: 1) Corrective: Information provided to users with a Field Safety Notice under Field Safety Corrective Action reference number ZFA-2024-00248. 2) Corrective: Information provided to users with an IFU update including the change communicated with and listed in the Field Safety Notice. 3) Corrective: An awareness notice was sent to the team involved in the drawing remediation for future changes. This notice should make the team aware that for parts that have to be tightened with another (and so should be cylindrical), feature on cylindricity is required. The requirement in regard to the thread should also be compatible between the two parts to be tightened. This notice should also precise which requirement must be added on the drawing in regard to the thread deformation.</fscaDescription> <fscaAdvice>Follow the assembling instructions written in the Field Safety Notice(s), and to make sure all affected personnel is aware.</fscaAdvice> <fscaProgress>Authorised Distributor "Biomet Global Supply Chain B.V." has conducted the FSCA in Estonia and identified 1 customer as affected on this FSCA. The details are as follows: Customers - 1 customer has signed the Field Safety Notice (FSN)</fscaProgress> <fscaTimeSchedule>As this is the final report, this FSCA is considered closed per Zimmer Biomet process.</fscaTimeSchedule> <fscaAttachmentFSNEnglish>0</fscaAttachmentFSNEnglish> <fscaAttachmentFSNNational>0</fscaAttachmentFSNNational> <fscaAttachmentFSNOther>0</fscaAttachmentFSNOther> <fscaAttachmentOther>N/A</fscaAttachmentOther> <fscaAttachmentStatus>Final</fscaAttachmentStatus> <fscaComments>1) Name of the co-ordinating NCACompetent Authority - Agence nationale de sécurité du médicament et des produits de santé (ANSM) 2) Information on submitter of the report Biomet Global Supply Chain Center B.V. is the centralized location within Zimmer Biomet for reporting Field Safety Corrective Actions to Notified Bodies, and to coordinating and affected National Competent Authorities. Below the contact details: - Name: Biomet Global Supply Chain Center B.V. - Contact name: Etienne Hereijgers - Address: Hazeldonk 6530 - Postcode: 4836 LD - City: Breda - Phone: +31767991050 - E-mail: [email protected] - Country: Netherlands 3) Additional National contact point information - Lebanon is not in the list of countries. Therefore, Netherlands is selected.</fscaComments> </fscaDesc> <fscaDistribution> <distributionEEA>AT</distributionEEA> <distributionEEA>BE</distributionEEA> <distributionEEA>CH</distributionEEA> <distributionEEA>CZ</distributionEEA> <distributionEEA>DE</distributionEEA> <distributionEEA>DK</distributionEEA> <distributionEEA>EE</distributionEEA> <distributionEEA>ES</distributionEEA> <distributionEEA>FI</distributionEEA> <distributionEEA>FR</distributionEEA> <distributionEEA>GB</distributionEEA> <distributionEEA>IE</distributionEEA> <distributionEEA>IS</distributionEEA> <distributionEEA>IT</distributionEEA> <distributionEEA>LU</distributionEEA> <distributionEEA>LV</distributionEEA> <distributionEEA>MT</distributionEEA> <distributionEEA>NL</distributionEEA> <distributionEEA>NO</distributionEEA> <distributionEEA>PL</distributionEEA> <distributionEEA>PT</distributionEEA> <distributionEEA>RO</distributionEEA> <distributionEEA>SE</distributionEEA> <distributionEEA>SI</distributionEEA> <distributionEEA>SK</distributionEEA> <distributionEUCandidates>HR</distributionEUCandidates> <distributionOutsideEU>Australia, Bosnia-Herzegovina, China, Faroe Islands, Japan, Qatar, Saudi Arabia, Singapore, South Africa &amp; South Korea.</distributionOutsideEU> </fscaDistribution> </fsca> Please wait... 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Saatja: "EUNLD FSCA GSCC" <[email protected]> Saaja: "TA Info" <[email protected]> Teema: Closure of FSCA # ZFA-2024-00248 - Estonia Kuupäev: 2025-08-08 11:26 Your Reference: Not provided Zimmer Biomet FSCA Reference: ZFA-2024-00248 Dear Sir / Madam, Zimmer Biomet would like to close the Field Safety Corrective Action reported under the Zimmer Biomet FSCA Reference listed above. Zimmer Biomet has completed this FSCA. Within the attached report, in section 7 “Description of the FSCA”, you may find: * CAPA information (in field “Description and justification of the action”) * Reconciliation details (in field “Progress of FSCA , together with reconciliation data”) Please do not hesitate to contact <mailto:[email protected]> [email protected] should you have any questions regarding this closure report. Met vriendelijke groet / Kind regards, Etienne Hereijgers Post Market Surveillance Distribution Senior Specialist (GSCC Hazeldonk) Hazeldonk 6530, 4836 LD Breda, The Netherlands Telephone: +31767991050 Email: <mailto:[email protected]> [email protected] - - - CONFIDENTIALITY NOTICE - - - This communication and any attachments hereto may contain confidential information. Unauthorized use or disclosure to additional parties is prohibited. If you are not an intended recipient, kindly notify the sender and destroy all copies in your possession.