BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLICATION INSTRUMENT FOR STERNAL ZIPFIX

    MDR report key: 7424994 · Received April 12, 2018

    Report

    Report Number
    8030965-2018-53037
    Event Type
    Injury
    Date Received
    April 12, 2018
    Date of Event
    March 19, 2018
    Report Date
    March 20, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JDQ
    UDI-DI
    07611819418424
    PMA / PMN Number
    K110789
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PART 03.501.080, LOT 9790420: RELEASE TO WAREHOUSE DATE: (B)(6) 2016. MANUFACTURING SITE: (B)(4). NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: ON THE DEVICE, HALF OF THE CUTTER COMPONENT IS BROKEN OFF. ON THE SURFACE OF THE INSTRUMENT ARE MINOR TRACES OF USE PRESENT. IN GENERAL, THE INSTRUMENT IS IN A GOOD CONDITION, NO FURTHER DAMAGES ARE VISIBLE. THE DIAMETER OF THE CUTTER HEAD WAS MEASURED AND NO DEVIATION OF THE MATERIAL CROSS SECTION NEAR THE BREAK WAS FOUND. A WEAKENING OF THE FRACTURE DUE TO INSUFFICIENT MATERIAL CROSS SECTION COULD NOT BE DETERMINED. THE MANUFACTURED AND CURRENT REVISIONS OF THE DRAWINGS WERE REVIEWED AND NO RELEVANT DESIGN CHANGES WERE IDENTIFIED. THE HARDNESS WAS MEASURED AND WAS WITHIN SPECIFICATION. IN ACCORDANCE TO THIS TEST RESULT IT CAN BE DETERMINED THAT THE CORRECT RAW-MATERIAL HAS BEEN USED. ACCORDING TO THE TEST RESULTS OF HARDNESS AND MATERIAL STRENGTH AT THE CROSS SECTION. NO REDUCED STRENGTH OF MATERIAL CAUSED THE BREAKAGE OF THE CUTTER. THEREFORE, IT IS LIKELY THAT MECHANICAL OVERLOAD HAS LED TO MALFUNCTION AND BREAKAGE OF THE CUTTER ON THE DEVICE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS NOTED THE BROKEN DEVICES WERE REMOVED EASILY AND THE SURGERY WAS CONSIDERED SUCCESSFULLY COMPLETED.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. (B)(4) - NO CODE AVAILABLE USED TO CHANGE IN SURGICAL PLAN. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING CORONARY ARTERY BYPASS GRAFTING (CABG) PROCEDURE ON MARCH 19, 2018, THE CUTTING PORTION OF THE APPLICATION INSTRUMENT FOR STERNAL ZIPFIX WAS BROKEN. AS A RESULT, SURGEON COULD NOT CLOSE THE STERNUM UTILIZING ZIPFIX BANDS. INSTEAD, SURGEON USED STEEL WIRE TO CLOSE THE STERNUM. SURGERY WAS DELAYED APPROXIMATELY 5 MINUTES DUE TO THIS ISSUE. THIS REPORT IS FOR ONE (1) APPLICATION INSTRUMENT FOR STERNAL ZIPFIX. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267998 APPLICATION INSTRUMENT FOR STERNAL ZIPFIX CERCLAGE FIXATION JDQ OBERDORF SYNTHES PRODUKTIONS GMBH 9790420 07611819418424

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention