BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNAL ZIPFIX W/NEEDLE PEEK SINGLE PACK

    MDR report key: 6671251 · Received June 27, 2017

    Report

    Report Number
    9612488-2017-10289
    Event Type
    Injury
    Date Received
    June 27, 2017
    Report Date
    June 14, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HEIGHT REPORTED AS 176 CM. PRODUCT DEVELOPMENT INVESTIGATION OF THE RETURNED DEVICES: TWO STERNAL ZIPFIX DEVICES WERE RETURNED WHICH SHOW SOME DEFORMATION TO THE DEVICE BODIES AND HEAD. ALSO BOTH DEVICES WERE NOT CUT PERPENDICULAR TO THE LOCKING HOUSING. SUSTAINING ENGINEERING DID NOT IDENTIFY ANY DESIGN RELATED ROOT CAUSE WHICH WOULD EXPLAIN THE ONE DEVICE FAILURE AS SEEN IN THIS COMPLAINT. THE USER USED LESS THAN THE RECOMMENDED NUMBER OF ZIPFIX IMPLANTS `5 ZIPFIX IMPLANTS`. THE APPLIED CONSTRUCT OF TWO ZIPFIX WITH ONE WIRE, WAS CONSEQUENTLY TOO WEAK TO HOLD THE PATIENT STERNUM TOGETHER AFTER THE INITIAL SURGERY. IF THE WIRE CUT THROUGH THE BONE FIRST OR IF THE ZIPFIX DEVICE WAS OVERLOADED AND FAILED FIRST CANNOT BE DETERMINED BY PRODUCT DEVELOPMENT. IT IS DEEMED THAT THE APPLIED CONSTRUCT WITH TWO ZIPFIX DEVICES AND ONE WIRE WAS INSUFFICIENT FOR THE PATIENT CONDITION. THIS NON-MANUFACTURING INVESTIGATION IS CLOSED BY SUSTAINING ENGINEERING AS IN-VALID. A DESIGN RELATED ROOT CAUSE IS EXCLUDED. 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

    (B)(4). DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6) PATIENT CODE (B)(4) USED FOR: ADDITIONAL INTERVENTION IS REQUIRED, HOWEVER, AT THE TIME OF THIS DETERMINATION THERE IS NO DOCUMENTATION THAT THE INTERVENTION HAS OCCURRED. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART #08.501.001.20S LOT #L210142 MANUFACTURING LOCATION: (B)(4) SUPPLIER: (B)(4) MANUFACTURING DATE: 07. MARCH 2017 EXPIRY DATE: 01. FEB. 2022 NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    DEVICE 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, DISLOCATIONS OF CLASPED STRIPS ON THE STERNUM, WHICH CAUSED THE STERNUM TO DISLOCATE AND THE NEED FOR REOPERATION BECAUSE THE DISLOCATION OF THE STERNUM PULLED BEHIND THE WIRE WHICH UNTIED. THE PATIENT IS INVOLVED BUT THERE WAS NO INTERVENTION, THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451635 STERNAL ZIPFIX W/NEEDLE PEEK SINGLE PACK CERCLAGE FIXATION JDQ SYNTHES BETTLACH L210142

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention